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Loss of power due to damaged battery cap
Medtronic Australasia Pty Ltd has notified the TGA about a product defect correction for damaged battery caps that are affecting the power supply of certain MiniMed 600 and 700 series Insulin Pumps. These damaged caps do not hold the battery into the circuit properly, resulting in a loss of power to the pump.
The following models of MiniMed Insulin Pumps are affected:
| Brand name | Model / Catalog numbers |
|---|---|
| MiniMed 620G Insulin Pump | MMT-1510, MMT-1710 |
| MiniMed 630G Insulin Pump | MMT-1515, MMT-1714, MMT-1715 |
| MiniMed 640G Insulin Pump | MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1725 |
| MiniMed 670G Insulin Pump | MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782 |
| MiniMed 700 Insulin Pump | MMT-1805 |
| MiniMed 770G Insulin Pump | MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892 |
| MiniMed 780G Insulin Pump | MMT-1885, MMT-1886, MMT-1895, MMT-1896 |
What do I need to do?
- Make sure you have an alternative means of insulin therapy in case the problem occurs and a spare battery cap is not available. If unsure about which alternative insulin therapy is right for you or the amount of insulin to inject, contact your doctor or diabetes care specialist.
- If you have one of the affected pumps:
check the outside of the battery cap, above the battery compartment
- check for cracking/obvious damage to the plastic.
- Do not remove the battery cap unless you need to replace it or the battery.
- If the battery cap is damaged, you must stop using the pump.
- Check if you have a spare undamaged cap. If you do, replace the damaged cap with the new one.
- If you don’t have a spare, you need to switch to your alternative insulin therapy.
- Call Medtronic at their Global Help line 1800-777-808 to report the damaged cap.
- If the outside of the battery cap looks undamaged but you need to replace the battery, make sure you have a spare cap available. The internal (facing into the battery compartment) parts of the battery cap may also be damaged.
- When replacing batteries:
- Check the metal contact on the inside of the battery cap to check if it is loose, damaged, or missing altogether. Also look for three (03) raised dots on each wing of the contacts. Do not attempt to adjust the metal contact.
Damaged battery caps – Do not use
Metal contact is missing, OR fewer than three raised dots can be seen.
Undamaged battery cap – Continue to use
Has three raised, round, black, plastic dots holding metal contact in place
- If you see any problems with the battery cap contact, or are unsure if it is damaged, immediately replace it with the spare cap.
- Call Medtronic at their Global Help line 1800-777-808 to report the damaged cap.
- If the battery cap contact is not damaged, continue to use your pump but check again for cap damage when you next replace your battery.
It is important to always keep an emergency kit that includes an insulin syringe and fast-acting insulin; and perform regular blood glucose testing (as directed in your MiniMed user guide).
- Please notify Medtronic of any adverse events, if the metal contact on your battery cap is damaged, or other quality problems associated with your use of this product at Global Help line 1800-777-808.
What is the problem?
If the metal contact becomes loose or falls off the battery cap, there will be an incomplete battery connection and the pump will not be powered. When the pump detects no power source, an ‘Insert battery’ alarm will occur, and insulin delivery will immediately stop. After 10 minutes, the alarm sound may increase to a siren, and the pump will turn off.
If insulin delivery is stopped, this could result in hyperglycaemia. In severe cases of hyperglycaemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
How will it be fixed?
Medtronic is designing a new cap and it will be issued to all the patients/consumers in early 2023.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products.
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.