FDA Issues Recall Notice for Malfunctioning Insulin Pumps

The U.S. Food and Drug Administration has informed people regarding the recall of certain malfunctioned insulin pumps. These insulin pumps, Medtronic MiniMed 600 series, have been used by individuals suffering from type 1 diabetes mellitus (T1DM).

T1DM, also called insulin-dependent diabetes, is a condition in which an individual’s pancreas fails to produce enough insulin for maintaining his/her blood glucose levels (BGLs).

Such patients require insulin from some external source in order to prevent their health from worsening. The use of insulin can also halt or delay complications of diabetes, such as nephropathy (kidney failure), neuropathy, retinopathy (blindness), and heart disease.

Though diabetes patients can receive insulin by self-injections, insulin pumps can be much more helpful for those requiring multiple doses of insulin per day. Diabetic patients can have a continuous supply of short-acting insulin to maintain blood glucose levels using these insulin pumps.

Insulin pumps not only avoid the use of long-acting insulin but also substitutes the daily need for multiple injections.

These small, portable, and computerized devices act in the same way as the human pancreas, supplying small and continuous doses of short-acting insulin (basal insulin).

Insulin pumps can also be utilized for delivering variable insulin concentrations after having a meal (bolus insulin).  The doctor provides help to the patients while setting basal insulin rates in the insulin pumps.

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And on the basis of a patient’s requirement, multiple basal settings can also be adjusted in these pumps. Among these insulin pumps, many are capable of calculating the mealtime insulin requirement on the basis of the number of carbohydrates a person is eating, and his/her blood glucose levels.

A person can attach this small device to his belt, place it in his pocket, or wear this pump around his/her waist or armband. These insulin pumps provide insulin via a catheter (small tube), attached with a cannula inserted into the subcutaneous fat layer, typically surrounding the area of the stomach.

MiniMed 600 series insulin pumps, developed by Medtronic is used by diabetes type 1 patients for keeping BGLs within the normal range. The basal insulin doses are adjusted by these devices every five minutes, based on the readings of CGM (continuous glucose monitoring).

According to the recent statement of the Food and Drug Administration, malfunctioning in these insulin pumps have injured over two thousand diabetic patients and resulted in the death of one. These malfunctioned pumps can cause serious medical problems due to their failure in delivering correct insulin doses for maintaining blood glucose levels.

The FDA has recalled these defected devices due to a broken or missing retainer ring, that is necessary for keeping insulin cartridges at their place. This recent recall, issued by the FDA, involves almost 322,000 insulin pumps.

The FDA has also mentioned that over 26,000 individuals have complained about these Medtronic MiniMed 600 series (model 630G and 670G) of insulin pumps. The diabetic patients, who are using these devices, are suggested to talk to their health care provider or to call Medtronic.

If an individual’s device is malfunctioned, it will be replaced by the Medtronic, but till then, he may have to use insulin injections temporarily.