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MiniMed Remote Controller MMT-503 used with MiniMed 508 Insulin Pump or Paradigm...

Published: November 26, 2021Recall ID: 7a431525-b6a2-4c63-aee4-e322aa57a2a0Category: generalCountry: Australia

Reason for Recall / Hazard

An unauthorised individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user’s remote controller and play those back later to deliver an additional bolus of insulin to the pump user or to suspend insulin delivery.

Product Description & Identification

Reason / Defects: An unauthorised individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user’s remote controller and play those back later to deliver an additional bolus of insulin to the pump user or to suspend insulin delivery. Hazards: If additional insulin is delivered beyond the user’s insulin requirements, this could lead to hypoglycaemia, or hyperglycaemia if insulin delivery is suspended. What to do: Remote controller users are advised to immediately stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to Medtronic. For further information, please contact Medtronic Global Help Line by phone on 1800 777808.

Affected Products

MiniMed Remote Controller MMT-503 used with MiniMed 508 Insulin Pump or Paradigm Pumps Product code: MMT-503 ARTG: 128416 (Medtronic Australasia Pty Ltd - Remote control - Cancelled)

Additional Source Details

FieldValue
Guid › #text7a431525-b6a2-4c63-aee4-e322aa57a2a0
Guid › @ is Perma Linkfalse
Linkhttps://www.productsafety.gov.au/search-consumer-product-recalls/minimed-remote-controller-mmt-503-used-with-minimed-508-insulin-pump-or-paradigm-pumps
Pub DateFri, 26 Nov 2021 00:00:00 +0000

Overview

  • Risk LevelPharmacy and medical products
  • DistributionAustralia
Official Agency Alert