Saturday, March 06, 2010

Insulin Pump Dangers? (Alabama/Georgia)

From lawyer Rob Bunch:

The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson.

According to the FDA panel papers, here are"Device Problems:"

The most frequently reported device problem in MDR’s related to insulin infusion pumps was ‘unknown,’ and the top five reporters identified “unknown” in 5421 of 16640 reports (19.7% of reports). The second most frequent device problem reported was “replace,” which accounted for 2385 entries (9% of reports).

Patient Problems included:
Patient Problems
The most frequently reported patient problems were 1) hospitalization, and 2) blood glucose high. Of the 16640 MDRs from the top five manufacturers, hospitalization was identified in 7967 reports (21% of reports) while blood glucose was identified in 6236 reports (16.6% of reports). The other most frequently reported patient problems reported were:
 Diabetic Ketoacidosis (8% of reports)
 Hyperglycemia (8% of reports)
 Treatment with medication (6% of reports)
 Blood glucose low (4.7% of reports)
 Therapy/non‐surgical treatment (4% of reports)

Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.

The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.


MiniMed Insulin Pumps
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.

Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.

Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.


Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.

Insulin Overdose Symptoms
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:

* Severe headache
* Increased/rapid heartbeat
* Nausea
* Tremors, anxiety
* Uncontrolled sweating
* Hypoglycemia

One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Symptoms include: cold sweats, confusion, double vision, convulsions, fatigue and general discomfort. Severe hypoglycemia can result in seizures, coma and death.

Call us today if you believe that an improperly functioning insulin pump has harmed you. Call Rob Bunch today. 256-764-0095