Medtronic MiniMed 640G insulin pumps
Published 21 February 2017
Product
MiniMed 640G insulin pumps with software version 2.6, model number MMT-1711. The MiniMed 640G is a portable insulin pump that is used to help people with diabetes maintain normal blood glucose levels. ARTG Number 95763. This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market.
Why it was recalled
Medtronic has identified a software issue that could prevent the internal battery from charging on some MiniMed 640G insulin pumps. If the issue occurs, an alarm is triggered and patients will see "Power error detected" and "25" displayed on the pump screen (power error 25). The message states "Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide."
Hazard
Potential loss of therapy due to battery power error. If the alarm is ignored and no action is taken to correct the problem, the user could develop dangerously high blood sugar levels (hyperglycaemia) which can cause serious health problems.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.