BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18768922 · Received February 23, 2024

    Report

    Report Number
    3008514395-2024-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 23, 2024
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF THE SUSPECTED DEVICE AND CHARGER FOUND THE CAUSE OF OVERHEATING TO BE CHARGER FAILURE. THE PLASTIC NEAR THE CHARGER USB-C CONNECTOR WAS MELTED AND WHEN CONNECTED TO A POWER SOURCE, THE CHARGER USB-C CONNECTOR QUICKLY REACHED ELEVATED TEMPERATURES. THE RETURNED DEVICE AND BATTERY WERE UNDAMAGED AND MAINTAINED A SAFE TEMPERATURE WHEN CHARGED USING A KNOWN-FUNCTIONAL CHARGER. PATIENT WAS ISSUED A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    PATIENT REPORTED THEIR BLOOD GLUCOSE METER FELT HOT TO THE TOUCH AFTER BEING PLUGGED IN TO CHARGE. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236903 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown