A serious default of a diabetes device in North Wales has been identified by an insulin management company.
Healthcare business Insulet has released the safety warning after detecting a fire risk of the Omnipod DASH Personal Diabetes Manager (PDM).
Initially issued in October, the safety warning has suggested that battery acid can leak from the PDM device and become too hot when it is on charge, which is a fire hazard.
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The PDM machine wirelessly manages an individual’s insulin delivery based on settings that they program themselves.
This then communicates wirelessly with the pod – a small, tubeless, wearable and waterproof device that you fill with insulin and wear directly on the body.
The notice states: “Our investigation has determined that the Omnipod DASH PDM is at an increased risk if charged to full capacity, particularly if left to charge for extended periods of time, for example overnight.
“Omnipod DASH PDMs in use more than 18 months may have an increased likelihood of this issue occurring.”
No injuries have occurred because of the technical issue, according to the insulin management company.
Signs of the fault include:
- The PDM does not turn on within 45 minutes of being connected to the charger or turns off immediately after being removed from the charger
- The PDM’s back cover bulging or not closing
- The PDM experiencing extreme overheating (uncomfortable to hold) or emits an odour, especially when charging
- If the PDM battery loses its charge very quickly or if it takes more than one and a half hours to reach 80% charge.
Nick Lyons, Acting Deputy Chief Executive and Medical Executive Director at Betsi Cadwaladr University Health Board, said: “We are aware of safety notice letters sent to all individuals that have an Omnipod DASH Personal Diabetes Manager due to reports from some users of battery issues.
“People have been sent information on what to do with their device, with advice depending on the symptoms it is having.”
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He added: “Insulet have updated the device which addresses the issue, and these are being delivered directly to people.
“If anyone is concerned about their Omnipod DASH Personal Diabetes Manager please contact Insulet’s Customer Care team at 0800 011 6132, or alternatively if you would like to speak to the Health Board directly please contact our Patient Advice and Liaison Service by calling 03000 851234 or email [email protected].”
An Insulet representative noted: “On October 17, 2022, we began distributing emails and letters to all Omnipod DASH users across the UK, repeating those communications until the user provided acknowledgement.
“As of December 5, 2022, we have sent six rounds of email communications and two rounds of letters through postal mail.”
They added: “Additionally, we are calling customers who have not yet acknowledged the Field Safety Notification.”
