BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18969538 · Received March 25, 2024

    Report

    Report Number
    3008514395-2024-00005
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 25, 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

    INSPECTION OF THE RETURNED MATERIALS CONFIRMED THAT THE PLASTIC AND GLUE ON THE USB-C CONNECTOR OF THE CHARGER MELTED INTO THE DEVICE CHARGING PORT CAUSING IT TO BECOME STUCK. APART FROM MELTED MATERIAL IN THE CHARGING PORT, THE RETURNED METER AND BATTERY SHOWED NO OTHER EVIDENCE OF DAMAGE OR MALFUNCTION. THE CAUSE OF THE ALLEGED MELTING WAS FOUND TO BE OVERHEATING OF THE USB-C CONNECTOR. PATIENT WAS ISSUED A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER CHARGER MELTED INTO THE METER ITSELF WHILE CONNECTED TO THE DEVICE. NO INJURY OR PROPERTY DAMAGE WAS ALLEGED AND NO MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10746 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown