BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 24070262 · Received January 14, 2026

    Report

    Report Number
    3008514395-2026-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 14, 2026
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE AND CHARGER WERE RETURNED TO PHILIPS FOR EVALUATION. THE CHARGER USB-C CONNECTOR (PLUGS INTO DEVICE) WAS FOUND TO BE MELTED AND DISCOLORED AND WOULD NO LONGER FIT IN THE DEVICE CHARGING PORT. TESTING OF THE BLOOD GLUCOSE METER ITSELF (SERIAL NUMBER (B)(6)) DEMONSTRATED IT MAINTAINED A SAFE TEMPERATURE WHILE CHARGING AND IT WAS FOUND TO BE UNRELATED TO THE EXCESSIVE HEAT ISSUE. INVESTIGATION FOUND THAT THE CHARGER USB-C CONNECTOR (PLUGS INTO DEVICE) HAD MELTED DUE TO EXCESSIVE INTERNAL HEATING. EXCESSIVE HEATING WAS DETERMINED TO BE CAUSED BY INGRESS OF MOISTURE LEADING TO A SHORT.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THE CHARGER PROVIDED WITH THEIR BIOTEL CONNECTED BLOOD GLUCOSE METER GOT HOT AND BECAME DISCOLORED WHILE CHARGING THE DEVICE. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132198 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female