BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 17279043 · Received July 7, 2023

    Report

    Report Number
    3008514395-2023-00002
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 9, 2023
    Report Date
    November 9, 2023
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ONLY REPORTED THAT THE DEVICE IN QUESTION WOULD NOT POWER ON OR CHARGE. PHILIPS WAS NOT MADE AWARE OF A REPORTABLE ISSUE UNTIL THE MALFUNCTIONING DEVICE WAS RETURNED FOR INSPECTION AND BATTERY DAMAGE WAS OBSERVED. THE DEVICE HAS BEEN SENT TO ORIGINAL SUPPLIER FOR FURTHER ANALYSIS TO DETERMINE ROOT CAUSE OF BATTERY DAMAGE/FAILURE.

    Additional Manufacturer Narrative · 0

    DEVICE WAS SENT TO VENDOR FOR FURTHER ANALYSIS TO DETERMINE ROOT CAUSE OF BATTERY DAMAGE/FAILURE. THE VENDOR WAS UNABLE TO ESTABLISH A DEFINITIVE ROOT CAUSE AND CONCLUDED THAT THE PROBABLE CAUSE WAS USE OF A NON-COMPATIBLE CHARGER ADAPTER.

    Description of Event or Problem · 0

    PATIENT REPORTED THEY WERE UNABLE TO TURN ON OR CHARGE THE DEVICE BUT DID NOT ALLEGE INJURY OR DEVICE DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. THE DEVICE WAS NOT OPERATIONAL, AND INSPECTION FOUND THAT THE BATTERY COVER WAS SLIGHTLY MELTED. WHEN THE BATTERY COVER WAS REMOVED, A CORNER OF THE BATTERY AND A PORTION OF THE BATTERY PORT WERE FOUND TO BE BURNED/MELTED.PATIENT REPORTED THEY WERE UNABLE TO TURN ON OR CHARGE THE DEVICE BUT DID NOT ALLEGE INJURY OR DEVICE DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. THE DEVICE WAS NOT OPERATIONAL, AND INSPECTION FOUND THAT THE BATTERY COVER WAS SLIGHTLY MELTED. WHEN THE BATTERY COVER WAS REMOVED, A CORNER OF THE BATTERY AND A PORTION OF THE BATTERY PORT WERE FOUND TO BE BURNED/MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055294 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown