BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23406325 · Received October 28, 2025

    Report

    Report Number
    3008514395-2025-00010
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    July 7, 2025
    Report Date
    October 28, 2025
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR EVALUATION. INSPECTION OF THE DEVICE DETERMINED THERE WAS MOISTURE INGRESS, WHICH LED TO EXCESSIVE HEATING AND MELTING OF THE CHARGE PORT. THE METER WAS EXPOSED TO MOISTURE BY THE PATIENT WHICH GOES AGAINST STANDARD HANDLING AND STORAGE OF THE DEVICE DESCRIBED IN THE USER MANUAL.

    Description of Event or Problem · 0

    PATIENT ALLEGES THE CHARGER WOULD NOT STAY IN THE CHARGE PORT OF THEIR PHILIPS BLOOD GLUCOSE METER. THEY ALLEGE THE CONNECTION GOT LOST BETWEEN THE POWER CORD AND THE CHARGE PORT. THERE IS NO EVIDENCE OR ALLEGATION OF INJURY OR MEDICAL INTERVENTION. DURING RETURN INVESTIGATION OF THE METER, THERE WAS EVIDENCE OF MELTING AROUND THE CHARGE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703936 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male