A health care company warns that a life-threatening failure in diabetic machines distributed in North Wales may cause fires.
Insulet has issued an urgent field safety advisory due to concerns that the Omnipod Dash Personal Diabetes Manager (PDM) may leak battery acid and overheat during charging.
The urgent notice was first published in mid-October, but Betsi’s patients, some of whom received their device in recent weeks, have not been warned until now, via a letter from the company.
The PDM is a mobile phone sized touch screen device that controls an insulin pump or ‘pod’.
The capsule is attached to the skin with an adhesive patch, and the PDM allows patients with type 1 diabetes to control the amount of insulin they receive.
But a failure in the PDM machine is causing a fire risk, and the company is now warning diabetic patients across North Wales.
The Urgent Field Advisory warns of PDM battery problems, battery swelling, battery fluid leaks, and extreme overheating, which can be a fire hazard.
The letter also warns that the risk increases with older machines.
“Our investigation has determined that the Omnipod DASH PDM is at increased risk if charged to full capacity, especially if left to charge for long periods of time, for example overnight,” the letter read.
“Omnipod DASH PDMs in use for more than 18 months may have a higher chance of this issue occurring.”
The company claimed that no injuries had been reported as a result of the glitch.
Warning signs to look out for include:
- The PDM back cover is bulging or will not close.
- The PDM experiences extreme overheating (uncomfortable to hold) or emits an odor, especially when charging.
- The PDM does not turn on within 45 minutes of connecting to the charger or turns off immediately after removing it from the charger.
- Or if the PDM battery discharges very quickly or takes more than an hour and a half to reach 80% charge.
Insulet was contacted for comment.
Nick Lyons, Acting Deputy CEO and Chief Medical Officer at Betsi Cadwaladr University Board of Health, said: “We are aware of the safety advisory letters being sent to all patients who have an Omnipod DASH Personal Diabetes Manager due to to some user reports of battery issues.
“Patients have been sent information on what to do with their device, with advice depending on the symptoms they are having. Insulet has updated the device that addresses the problem, and these are being delivered directly to patients.
“If any of our patients have concerns about their Omnipod DASH Personal Diabetes Manager, please contact Insulet’s customer service team on 0800 011 6132 or alternatively if you wish to speak directly to the Board of Health, please contact our Customer Service. advice and liaison for patients by calling 03000 851234 or email [email protected]”.
Patients experiencing issues are warned not to charge their Omnipod Dash PDM and are advised to contact Insulet’s customer service team immediately on 0800 011 6132.
By Richard Evans – BBC Local Democracy Reporter
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