Paradigm Insulin Pump users have an Urgent Medical Device Safety Notification Letter about Infusion Sets and an Urgent Medical Device Recall Notice about Reservoirs, equipment used to operate the Paradigm insulin pump that are critically important. The Infusion Sets and Reservoirs are medical equipment necessary to keep diabetics alive, by administering appropriate amounts of insulin, but instead may be putting them in danger.
The Urgent Medical Device Safety Letter warns that if insulin or other liquids come in contact with the inside of the connector to the Infusion Set, where the Reservoir is connected to the Infusion Set tubing, it can temporarily block vent membranes, causing too little or too much insulin to be delivered. If this happens, either Hyperglycemia (too high a blood sugar level) or Hypoglycemia (too low a blood sugar level) results, which can produce loss of consciousness, coma or even death. One way to recognize if the Infusion Set membranes have been blocked is if during the priming process, insulin continues to drip from the infusion set needle/cannula when priming is completed. The Safety Notification Letter provides instructions on how to minimize liquid from getting in the connector. To minimize insulin from wetting the connector, it is suggested that the insulin vial be held in your hand, below the Reservoir and blue transfer guard, when the Reservoir has been filled and is being removed. The Paradigm Infusion Sets that are affected by this are Models
MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975
Should liquid get into the connector, discard that Infusion Set and the Reservoir, and start over with a new Infusion Set and Reservoir.
Medtronic has also issued an Urgent Medical Device Recall Notice recalling certain lots of MMT-326A and MMT -332A Reservoirs used with the Paradigm insulin pump due to the potential threat of the Reservoirs leaking insulin. Certain lots were manufactured with an extra groove in the black O-ring in the Reservoir, which can cause insulin to leak from the back of the Reservoir. This results in not enough insulin being delivered and there will be no warning that this is occurring. Several Paradigm users have already been hospitalized in Diabetic Ketoacidosis (“DKA”), a serious condition that causes a severe impact to health, including death. Symptoms of DKA include nausea, vomiting, shortness of breath, and excess thirst and urination. The Lot numbers of the affected Reservoirs are available here. DO NOT use these Reservoirs and contact Medtronic for free replacements.
For more information: click here or call the 24-hour Helpline at 888-204-7616. For replacements call 866-450-0890.
You may report any adverse reactions or quality problems that you have to FDA’s MedWatch Adverse Event Reporting program online or by phone at 800-FDA-1088 or by Fax at 800-FDA-0178.