Udi: (b)(4).The customer reported a statstrip glucose meter with serial number (b)(6) was being used when the screen started flashing and sparks were seen from the enclosed battery compartment.This occurred on july 23, 2021.The meter was taken out of service, and therefore, did not result in patient or user harm.The meter was returned to nova biomedical corp.For investigation.The investigation resulted in the determination the back-up, button-cell battery had become dislodged after the supplier adhesive seal failed.The battery then shifted within the device to a position where it was in contact with other powered electrical components, allowing the battery to overheat.Device history record (dhr) reviews were performed for the meter by a quality control engineer.The review included an assessment of the production, testing, and release of the meter.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.A review of manufacturing variance documents showed this problem was previously documented and a corrective action had been implemented after the manufacture of the meter under investigation.The corrective action includes a uv-cured adhesive to secure the button-cell battery in the proper position.The conclusion of the investigation is the reported customer complaint was due to the dislodgment of the internal button-cell battery from the proper positioning.The root cause was identified as a failure in the supplier adhesive seal designed to keep the internal battery in the proper position.Nova biomedical will continue to monitor for recurrence of similar events.
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