Medtronic Recalls 60,000 Sets Of Medical Supplies Used For Insulin Pumps Over Concerns About Safety

With a sizable percentage of nursing home patients diagnosed with diabetes, we have been contacted by a number of current and former clients regarding a product recall involving Medtronic's MiniMed Paradigm insulin pumps.  The medical device recall was initiated in July, 2009 after defects were discovered in a particular lot of the infusion sets

insulinpumpInfusion sets are the thin, plastic tubing that delivers insulin from an insulin pump to the patient's body. 

The recalled infusion sets can be identified by both the lot number (Lot 8, Quick-set infusion sets) and the reference numbers: MMT-396, MMT-397, MMT-398 and MMT-399 (lots starting with a number '8').

The problems with the infusion sets identified above is that the tubing may not allow the insulin pump to vent the pressure properly with may result in the patient receiving too much or too little insulin which in turn could result in a severe injury or death.

According to Medtronic, if your loved one uses a 'Quick-Set' Infusion Set and is used identified within the lots above, you should stop using the device immediately.

Further, if you believe your loved one died or suffered an injury including: hypogylcemia or hyperglycemia following use of a Medtronic infusion device, you may be entitled to compensation from the manufacturer.  In order to determine if your case fits within the parameters, you should safeguard the packaging and contact a medical device attorney for a consultation. 

Related:

Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States, FDA July 10, 2009

Never Event #3: Poorly Controlled Blood Sugar, Hyperglycemia & Hypoglycemia

Diabetic Ketoacidosis Is An Under-Appreciated Danger Facing Many Nursing Home Patients

Nursing Home Spotlight: Fairview Nursing Plaza, Rockford, IL

On October 28, 2009, the Illinois Department of Public Health (IDPH) fined Fairview Nursing Plaza (a large, 213 bed “skilled and intermediate care facility” located in Rockford, IL) $10,000 for fourth quarter nursing home violations.  These violations included Nursing Home Care Act violations involving improper and inaccurate documentation of diabetes treatment and monitoring, and failure to immediately arrange for ambulance transport for a diabetic resident suffering from diabetic ketoacidosis. 

Also in October 2009, IDPH fined Fairview $10,000 for violating the Nursing Home Care Act (for a Type “A” Violation relating to the area of nursing).  A survey conducted on September 28, 2009 revealed that documentation for insulin dependent diabetics was not always complete and accurate.  This finding was confirmed by the facility’s own Director of Nursing.  The facility failed to properly and accurately document blood glucose levels and scheduled doses of insulin for insulin dependent diabetics residing in the facility. 

Diabetes (Type 1) can be a difficult disease to manage.  It requires careful screening of blood sugar levels, proper nutrition, and insulin shots.  There are many diabetes related complications, and the best way to reduce the risk of complications is to keep blood sugar level close to normal most of the time.  Fairview’s failure to properly document blood sugar levels and treatments put all of its diabetic residents at increased risk of diabetes complications. 

The nursing home failed to immediately arrange ambulance transport services for one diabetic resident with sustained elevated blood glucose levels, resulting in him suffering from diabetic ketoacidosis (too little insulin in your body).  The nurse reported that she checked the resident’s blood glucose levels hourly between 7:45 - 11:30 AM. 

Despite “HI blood glucose results” (> 525 mg/dl), the nurse did not notify a doctor sooner because she thought he was ok, even though the resident was showing signs of confusion, limp limbs, and being unstable sitting in a chair.  (see “Diabetic Ketoacidosis is an Under-Appreciated Danger Facing Many Nursing Home Patients”)  The nursing home’s failures directly endangered the life of this resident, and also call into question whether the nursing staff was properly monitoring other diabetic residents. 

Diabetic ketoacidosis is a very serious complication of diabetes.  Because sugar can no longer enter cells to provide energy, your blood sugar rises, and your body breaks down fat for energy.  This produces ketones, which are toxic, and if left untreated, it can be fatal.  Symptoms include: excessive thirst, frequent urination, nausea and vomiting, abdominal pain, loss of appetite, weakness or fatigue, shortness of breath, fruity-scented breath, and confusion. 

Fairview has a history of higher than average Health Deficiencies.  The Medicare Nursing Home Compare gave Fairview Nursing Plaza an overall rating of one out of five stars, which is much below average rating.  Health Inspections rating was one star (20 Health Deficiencies between 12/1/08 – 2/28/10.  Nursing Home Staffing rating was also only one star.  Quality Measures rating was four stars.  Between 12/1/07 and 11/30/08, the facility received 19 Health Deficiencies. 

The recent health violations at Fairview call into question whether the facility’s residents, especially its diabetic residents, are receiving proper care and treatment.  Diabetes is only one common condition affecting older nursing home residents.  Many common diseases and conditions require close supervision and monitoring to prevent dangerous complications and ensure proper medical care. 

SIR Management Inc.

Fairview Plaza Nursing Center is a facility operated under the control of S.I.R. Management, Inc. S.I.R. Management is a health care consulting company located in Lincolnwood, Illinois, which consults to several Nursing Facilities (Nursing Homes) in the Chicagoland area, including:

  • Columbus Park Nursing and Rehabilitation Center
  • Elmwood Care
  • Maplewood Care
  • Neighbors Rehabilitation Center
  • Regency
  • Albany Care
  • Greenwood Care
  • Decatur Manor
  • Rock Island Nursing & Rehabilitation
  • Wilson Care
  • Bryn Mawr Care

Sources:

Fairview Plaza Nursing Center

Medicare: Nursing Home Compare – Fairview Nursing Home

Illinois Department of Public Health: Fairview Nursing Home

IDPH: Fairview Nursing Home – 4th Quarter Violations

Mayo Clinic: Diabetic Ketoacidosis

Nursing Home Abuse Blog: Diabetic Ketoacidosis is an Under-Appreciated Danger Facing Many Nursing Home Patients

 

Little Known Ways to Prevent Hypoglycemia Using Fitness Exercises

Regulation of glucose levels is a crucial part of caring for many nursing home patients.  In addition to diet, exercise can also help in regulating blood sugar.  Here are some great tips from Su Rollins.  Thanks Su!

What effect does exercise have on glucose levels?

When exercising, muscles use glucose for energy. At first, the body uses glucose converted from glycogen in the muscles. Then, glucose is taken from the bloodstream. During prolonged exercise, in order prevent blood glucose levels from becoming too low, glucagon and additional hormones are released. These hormones trigger the breakdown of stored fat into components the liver can convert into more glucose. With frequent and regular exercise, the body’s sensitivity to insulin improves and better glycemic control is developed.

Why is the effect of exercise on glucose levels important to those with type 2 diabetes?

Exercise indeed has a good effect on a patient’s glucose level. This is good news for people who have type 2 diabetes. A lot of research indicates that patients of diabetes gain more control over their glycemic as soon as they get used to a regular exercise program. On the other hand, people who do not engage in exercise find no improvement on their glycemic control. Since exercise improves your insulin sensitivity, you will also need less medicines in order to control the levels of your blood sugar.

Should patients with type 2 diabetes exercise more often or differently than otherwise healthy people?

Experts recommend that people who have type 2 diabetes should exercise around two and a half hours (usually only moderate aerobic activity) three days a week. Alternately, they could also do only vigorous aerobic activity for ninety minutes

What type of exercise is best for type 2 diabetes patients?

When it comes to exercise, the kind of exercise that is used is not as important compared to the frequency of the exercise. There are also some studies showing that if you participate in both weight training and aerobic activity, you get even more benefits as a result.

When should patients be discouraged from exercising?

Of course, sometimes patients should not engage in vigorous exercise especially when they have cardiac conditions or they are more prone to developing injuries as a result. It is better if they start of slow and get used to a light intensity program instead.

How might a patient be encouraged to exercise?

You can encourage patients to exercise slowly and surely until they adapt to it.

About the Author - Su Rollins writes for hypoglycemia diet and reactive hypoglycemic diet, her personal hobby blog focused on tips to prevent and cure hypoglycemia using the right diet and nutrition.

Family Alleges Nursing Home's Failure To Control Diabetes Resulted In Death Of Patient

The family of retired Judge John Philips has filed a nursing home negligence lawsuit against Prospect Park Residence alleging the facilities failure to treat the man's diabetes resulted in his death. According to the lawsuit, the staff failed to provide him with a specialized diabetic menu and failed to administer his insulin on a regular basis. 

According to Philips long-time friend John O'Hara, "He had diabetes that was supposed to be controlled.  They kept screwing up.  They killed him." 

The lawsuit seeks $10 million from this New York nursing home.  Read more about this lawsuit here.

Diabetic Nursing Home Patients

According to the American Diabetes Association, approximately 18.3% (8.6 million) of Americans age 60 and older have diabetes. The prevalence of the disease increases with age; an estimated 50% of all diabetes happens in those aged 55 and older. The risk of developing type 2 diabetes also increases with age.

Particularly in patients with type 2 diabetes, age causes a decline in insulin production and an increase in glucose intolerance. Older Americans are also more likely to have complicating conditions such as retinopathy, hypertension, ketoacidosis and kidney problems.  Nursing home staff should carefully monitor glucose levels and make every effort to timely administer insulin if necessary.

Related:

Diabetic Ketoacidosis Is An Under-Appreciated Danger Facing Many Nursing Home Patients

Diabetic Ketoacidosis Is An Under-Appreciated Danger Facing Many Nursing Home Patients

Diabetes is a serious illness affecting many nursing home residents.  Diabetics face an increased risk for a variety of health problems and complications, including ketoacidosis.  Diabetic ketoacidosis is a dangerous complication of diabetes that occurs when you don’t have enough insulin in your body.  This serious complication is more common in people who have type 1 diabetes, rather than type 2 diabetes. 

Diabetic ketoacidosis develops when you have too little insulin in your body, raising your blood sugar level.  This causes your body to break down fat for energy, creating toxic acids known as ketones.  If left untreated, this can cause you to lose consciousness and even result in death.  Symptoms develop quickly and include:

  • Excessive thirst
  • Frequent urination
  • Nausea and vomiting
  • Abdominal pain
  • Loss of appetite
  • Weakness or fatigue
  • Shortness of breath
  • Fruity-scented breath
  • Confusion. 

Doctors can test for high blood sugar level and high ketone level in your urine in order to confirm ketoacidosis. 

Ketoacidosis is commonly triggered by an illness or a problem with insulin therapy.  Elderly diabetic nursing home residents are more susceptible to infection and other illnesses, which in turn puts them at greater risk for developing ketoacidosis.  However, the risk of ketoacidosis is highest if you are age 19 or younger and suffering from type 1 diabetes.  Other possible triggers include: stress, physical or emotional trauma, high fever, surgery, heart attack, stroke, and alcohol or drug abuse. 

Treatment of ketoacidosis is done with fluid replacement, electrolyte replacement, and insulin therapy.  These very treatments that are used to correct ketoacidosis are also the source of most ketoacidosis complications.  These complications include: low blood sugar (hypoglycemia), low potassium (hypokalemia), and swelling of the brain (cerebral edema). 

The best way to prevent ketoacidosis is to properly manage your diabetes with healthy eating and physical activity as well as monitoring your blood sugar level to ensure that it remains within your target range. 

Many nursing home residents rely on nursing home staff to properly monitor their blood sugar level and adjust insulin dosage as needed as well as provide healthy and well-balanced meals.  Therefore, it is important that nursing homes develop care plans to provide adequate care and services to manage diabetic residents.  Most diabetic complications develop faster in elderly diabetics with poor glycemic control.

Diabetes in the Elderly

Diabetes is a serious disease that can cause many complications for elderly diabetics.  Ketoacidosis and other diabetic complications require that nursing home staff take special precautions to properly monitor diabetic residents and ensure that they receive necessary care and services to attain and maintain the highest quality of life possible. 

If you worry that a nursing home facility is not providing adequate care to manage your diabetes, it is important that you take immediate action to get your diabetes under control and prevent medical problems and complications. 

Resources:

Medicine Net: Ketoacidosis

Diabetes Disease: Ketoacidosis

Journal of Geriatric and Gerontology: Diabetes in the Elderly

Resident Grand Rounds: Diagnosis and Management of Diabetic Ketoacidosis in Adults

Nursing Homes Abuse Blog:

Nursing Homes Must Be Prepared To Handle Diabetic Patients

Never Event #3: Poorly Controlled Blood Sugar, Hyperglycemia & Hypoglycemia

About Jonathan Rosenfeld

Photo of Jonathan Rosenfeld

Jonathan Rosenfeld is a lawyer who represents people injured in nursing homes and long-term care facilities.   Jonathan has represented...

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