Medtronic MiniMed 640G insulin pumps

Official notice

21 Feb 2017

Last checked

21 Feb 2017

Risk not stated by sourceACCC

An official ACCC notice concerns Medtronic MiniMed 640G insulin pumps. 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. Published 2017-02-21.

What to do now

If you or someone you provide care for use a MiniMed 640G insulin pump, you should respond promptly to any alert message displayed on the pump screen. If you encounter the "25" error, you should call the 24-hour Medtronic Helpline on 1800 777 808 (selecting option 1) for assistance. Callers will be assisted to determine the cause of the alarm and be guided through the pump reset process. If the error cannot be corrected, the pump will be replaced. This is a recall for product correction - the pumps are not being physically recalled and are not being removed from the market. Medtronic Australasia has written to people who use a MiniMed 640G insulin pump, as well as to relevant health professionals to provide further information about this issue. If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can contact Medtronic Australasia on 1800 777 808 (option 1).

Recall number

6bf8a7eb-bc06-4580-a846-766a4f34adaf

Official notice

2017-02-21

The 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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

95763

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Affected products

Product 1

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.

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

unspecified

Recall details

Recall number

6bf8a7eb-bc06-4580-a846-766a4f34adaf

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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