INSULET Australia Pty Ltd has informed the Therapeutic Goods Administration (TGA) that is has received reports of problems with the Omnipod DASH Personal Diabetes Manager (PDM).
The company has warned that issues, including battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard, have been identified.
The TGA noted that all Omnipod DASH PDM units with the part number PT-000011 and reference numbers PDM-INT2-D001-MM or SKT-AUS-D001-MM and UDI number, 10385082000146, may be impacted by the issues.
Health professionals and patients are encouraged to report problems with medical devices to the TGA Incident Reporting and Investigation Scheme, if they identify issues.
The above article was sent to subscribers in Pharmacy Daily's issue from 16 Nov 22
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