UK Medical Device Alert Issued Over Medtronic Insulin Infusion PumpMay 30, 2014
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently issued a Medical Device Alert over the Paradigm ambulatory insulin infusion pump manufactured and marketed by Medtronic Inc.
The MHRA is a United Kingdom government agency responsible for drug and medical device safety and efficacy. The MHRA is similar to the U.S. Food and Drug Administration (FDA).
The recalled Medtronic Paradigm ambulatory insulin infusion pumps include the following models: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754.
The American Diabetes Association explains that insulin pumps are small, computerized medical devices created to deliver insulin in one of two ways. Delivery is made by either a steady, measured, continuous dose, known as the "basal" insulin, or as a surge, or "bolus" dose. The bolus dose is made at the user’s direction, and is typically delivered at mealtime. Insulin doses are delivered through a flexible plastic tube—or catheter—that also involves the use of a small needle. The catheter is then inserted through the skin, into the fatty tissue, and taped in place. The insulin pump does not replace the patient’s need to monitor blood glucose levels; however, the pump may help some patients achieve increased control over their sugar levels.
The May 29, 2014 MHRA alert was announced over a risk of hypoglycemia due to incorrect selection and delivery of the bolus amount of insulin. Medtronic indicated that it has received reports of users accidentally programming the pump to deliver the maximum bolus amount.
Hypoglycemia is a condition in which glucose levels drop below 70 mg/dL. When blood glucose levels drop below this amount, patients may experience serious harm.
The MHRA indicated that medical personnel and patients are to receive a copy of Medtronic’s “Field Safety Notice” (FSN), which is dated March 2014. The MHRA also indicated that the recommendations in the Medtronic FSN document be followed and that patients and caretakers using Medtronic’s Paradigm ambulatory insulin infusion pump:
- Be aware that, when programming insulin doses through the “Main Menu,” scrolling down enables the displayed dose on the screen to go from 0.0 units to the maximum programmed insulin dose.
- Confirm that the insulin dose that flashes on the display screen is correct prior to initiating insulin delivery.
- Ensure that the “Max Bolus” and “Max Basal” settings are programmed according to individual insulin needs, as determined by the healthcare professional.