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OECDReference EN/AU/PS1101077

All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps

Official information organised for easier consultation. The source publication remains authoritative.

Identification

Product identification

Product
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps

Official information

Risk and measures

Risk or hazard
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. 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.
Recommendations
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.

Official information

Economic operators

Manufacturer
Medtronic Australasia Pty Ltd

Territory

Geography

Distribution
Retirada en Australia
Country of recall
Australia

Provenance and context

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