Beginning in April 2013, the Medtronic Paradigm® Insulin Pump has been the subject of a number of medical device safety alerts and recalls issued by its manufacturer and the U.S. Food and Drug Administration (FDA). The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs.
The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Medtronic recalled the pumps because the pump’s drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is exposed to water, it may result in damage to the pump’s internal electronics, which can prevent the pump’s buttons from working properly or can cause the pump to alarm.
Model numbers affected by this recall include: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. The recall includes about 428,000 units distributed worldwide.
On June 7, 2013, the FDA issued a Class I Recall on Medtronic MiniMed Paradigm Infusion Sets. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. If insulin or other fluids come in contact with the inside of the tubing connector, it can temporarily block the vents that allow the pump to properly prime.
If the pump’s vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia. In extreme cases, these conditions may cause loss of consciousness or death.
The Paradigm infusion sets are intended for use with the Paradigm insulin infusion pump. Infusion sets are used by patients with diabetes who require administered insulin to maintain acceptable blood glucose levels.
This recall affects the following model numbers: 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 Paradigm Infusion sets.
On July 3, 2013, Medtronic sent an urgent medical device recall notice to its customers alerting them of problems with certain lots of MMT-326A and MMT-332A Reservoirs used with Paradigm Insulin Pumps. According to the notice, the recall was issued because of the potential for the reservoirs to leak. A leak in the reservoir may result in delivery of less insulin than intended. Also, a leak may lead to an insulin blockage in the infusion set, and a failure of the device to sound an alarm to notify patients. Medtronic says the defect is caused by abnormal wear on a tool used to manufacture reservoir stoppers. They are recalling all lots of reservoirs that contain stoppers manufactured with this tool.
Medtronic advised patients who obtain reservoirs from mail order suppliers, distributors, pharmacies or their physician’s office, or any other source, to check lot numbers to determine if they may be affected. Medtronic will replace all reservoirs from affected lots at no cost to patients.
Lots affected by the Medtronic Reservoir recall are: H8416432, H8461538, H8489386, H8512826, H8420977, H8463297, H8491921, H8515317, H8422490, H8464121, H8492449, H8517079, H8424676, H8467888, H8494645, H8521052, H8437486, H8469703, H8496561, H8539013, H8441420, H8471745, H8500423, H8541843, H8442973, H8473106, H8500472, H8584244, H8451531, H8473271, H8503372, H8603292, H8452933, H8476270, H8503728, H8604958, H8455959, H8478398, H8509305, H8627745, H8457716, H8485398, H8510440, H8635301, H8459557, H8486688, H8512566.
The lot numbers are located on the side panel of the reservoir box, as well as on the side of the individual reservoir packaging. The lot number starts with an “H” and is followed by a 7-digit number. Patients are advised not to use any of the recalled reservoirs and to dispose of them immediately, and to use a backup plan or device for insulin delivery.
Beasley Allen is currently investigating claims of serious injury or death as a result of a defective Medtronic Paradigm® Insulin Pumps, Medtronic MiniMed Paradigm Insulin Infusion Sets and Medtronic Infusion Set Reservoirs.
FDA Recall – Medtronic MiniMed Paradigm Insulin Infusion Pump
FDA Recall – Medtronic MiniMed Paradigm Infusion Sets
Urgent Medical Device Safety Notice – Medtronic Infusion Sets
Urgent Medical Device Recall Notice – Medtronic Reservoirs