The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function.
If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said.
The risk of vibrator alarm failure and intermittent audible alarm failure is due to an electrical issue. The alarm failures will be noted during a pump’s self-test, according to the regulatory body, which starts when a user changes the battery or insulin cartridge. If the pump detects a failure, it will display an ‘E7’ error message.
All patients and caregivers should check the insulin pump’s display regularly and contact Roche Careline to get a replacement if the pump continually displays an ‘E7’ error message.
The regulatory body also advised that patients return the Field Safety Notice acknowledgement form to Roche, saying that the manufacturer has not yet received sufficient responses.
The deadline for all patients and caregivers to have received Roche’s Field Safety Notice is Oct. 18.