Published: 17 July 2013

Safety Information

Medtronic Paradigm Insulin Pump Reservoirs

Medtronic MiniMed Model MMT-326A and MMT-332A Insulin Reservoirs

Medtronic is recalling the following batches of the Medtronic MiniMed Model MMT-326A (1.8mL) and MMT-332A (3.0mL) Insulin Reservoirs.

Affected Batch Numbers*

H8442973	H8469703	H8496561	H8517079
H8463297	H8492449	H8510440	H8539013
H8467888	H8494645	H8512826

* There are 47 affected batch numbers worldwide, but only the above 11 have been supplied in New Zealand

Issue

These reservoirs are being recalled due to the potential for there to be an increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm as designed.

Actions

Patients are being advised to check their reservoir batch numbers to see if they are on the recall list. The batch number is on the side panel of the reservoir box and on the packaging of each individual reservoir.

Reservoirs from unaffected batches can continue to be used but reservoirs from the affected batches should not be used.

Patients who only have reservoirs from affected batches should switch to their back-up insulin injection plan.

Individual patients are being contacted about this issue.  However, if not contacted, affected patients should call Medtronic for advice.

Any patients with questions or concerns about this issue, or who want to arrange replacement of affected reservoirs should phone the Medtronic New Zealand Diabetes 24 Hour Helpline on 0800 633 487.