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Medtronic MiniMed insulin reservoirs (MMT-326A and MMT-332A models)
Recall - Increased risk of leaking
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recalling certain batches of the following models of its Medtronic MiniMed insulin reservoirs:
- MMT-326A (1.8 mL reservoir)
- MMT-332A (3 mL reservoir)
The affected batch numbers that have been supplied in Australia* are:
* There are 47 affected batch numbers worldwide, but only the above 14 have been supplied in Australia.
Medtronic MiniMed insulin reservoirs are a single-use medical device intended to be filled with insulin and used with Medtronic Paradigm insulin pumps for the management of insulin-dependent diabetes.
It has been identified that the above batches of the reservoirs have an increased risk of leakage, which could result in less insulin being delivered than intended.
An investigation of the manufacturing process has revealed the cause of the issue. The problem has now been corrected and extra testing and inspection steps have been introduced to avoid similar issues in the future.
Medtronic Australasia has written to Medtronic Paradigm insulin pump users who have received Medtronic MiniMed insulin reservoirs from an affected batch, providing further information about this issue and advice on how to arrange replacement of any reservoirs they currently have (at no cost).
Users should check the batch numbers of any unused Medtronic MiniMed insulin reservoirs to see if they are affected by this recall. The batch number can be found on the side panel of the reservoir box and on the packing of each individual reservoir (see picture below).
Do not use reservoirs from the affected batches.
If you only have reservoirs from affected batches, switch to your back-up insulin injection plan (as developed with your health professional) and call Medtronic Australasia on 1800 777 808 to arrange replacements. Dispose of all affected reservoirs — they do not need to be returned to Medtronic Australasia.
Please note all of the information provided by Medtronic Australasia and follow any other instructions relating to this recall.
If you have any questions or concerns about this issue, please phone Medtronic Australasia on 1800 777 808. Alternatively, you can speak to your diabetes nurse educator or other health professional.
Please note that Medtronic Australasia has written to Medtronic Paradigm insulin pump users who have received Medtronic MiniMed insulin reservoirs from an affected batch, providing further information about this issue and advice on how to arrange replacement of any devices they currently have (see 'Information for consumers').
If you have any questions or concerns about Medtronic MiniMed insulin reservoirs, please phone Medtronic Australasia on 1800 777 808.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.