PRA number
Published date
Product description
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
MiniMed pumps are intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin.
ARTGs 95763, 308140, 332201 and 376091
Reasons the product is recalled
The gold battery cap contact may fall off when the user is charging the battery. If the contact falls off, the 'Insert battery' alarm will not clear automatically when the user inserts a new AA battery as the circuit is not complete. This will result in the alarm escalating to a siren and then the pump will shut down and will not power up.
The hazards to consumers
If insulin delivery is suspended, this may lead to major hyperglycemia which can result in serious health complications.
In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
What consumers should do
Medtronic will contact affected users in writing to advise them of the issue. Consumers are advised to follow the interim actions outlined in the customer letter and to have an alternate means of insulin therapy available.
For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00725-1
For further information, please contact Medtronic Technical Support by phone on 1800 777 808.
Supplier
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.