Device Alert

 

HPS Pharmacies wish to advise that Medtronic have given notice of three potential but rare issues with its Medtronic Paradigm Insulin Pump.

The affected model numbers are:

MMT-511 MMT-712
MMT-512 MMT-715
MMT-515 MMT-722
MMT-522 MMT-754
MMT-554

 

The notice has been issued because:

  1. Loose drive support cap – There have been reports of loose drive support caps, probably due to being dropped. If the drive support cap is loose, the pump should not be used until serviced by Medtronic. Diabetes should be managed according to the back-up plan.
  2. Sensor graph timeout – Paradigm VEO (MMT-554 and MMT-754) pumps using the Low Glucose Suspend feature of Continuous Glucose Monitoring.
    The sensor graph timeout should be set to 2,4, or 6 minutes, but NOT set to ‘None’, as the auto-resume may be delayed by two hours after a low glucose event, resulting in increased blood glucose levels.
  3. Water damage – The pump is designed to withstand splashing or brief dunking, but should not be immersed in water. Following accidental immersion, it should be dried and functionality verified using the self-test option in the Utilities menu.

Please retain this notice in a prominent position, including other related business units as a reminder for all staff members who may encounter patients using these pumps, and report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies or Medtronic’s Helpline on 1800 777 808 (option 1).

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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