BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23033369 · Received September 11, 2025

    Report

    Report Number
    3008514395-2025-00005
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Report Date
    December 12, 2025
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OVERHEATING CHARGER ISSUE WAS NOT REPORTED BY THE PATIENT AND WAS IDENTIFIED AFTER IT WAS RETURNED DUE TO AN ALLEGATION THAT IT WOULD NOT CHARGE THE DEVICE BATTERY. THE BGM ASSOCIATED WITH THE FAULTY CHARGER (SERIAL NUMBER TF100484) WAS FOUND TO BE UNRELATED TO THE OVERHEATING CHARGER ISSUE. THE AFFECTED CHARGER WAS RETURNED TO THE ORIGINAL SUPPLIER FOR ADDITIONAL INVESTIGATION. SUPPLIER INVESTIGATION FOUND LIQUID HAD MADE ITS WAY INTO THE USB-C CONNECTOR OF THE CHARGER LEADING TO A SHORT AND CAUSING IT TO OVERHEAT. ISSUE IS ATTRIBUTED TO USE ERROR AS CHARGER IS NOT INTENDED TO BE EXPOSED TO LIQUID.

    Additional Manufacturer Narrative · 0

    OVERHEATING CHARGER ISSUE WAS NOT REPORTED BY THE PATIENT AND WAS IDENTIFIED AFTER IT WAS RETURNED DUE TO AN ALLEGATION THAT IT WOULD NOT CHARGE THE DEVICE BATTERY. THE BGM ASSOCIATED WITH THE FAULTY CHARGER (SERIAL NUMBER (B)(6) WAS FOUND TO BE UNRELATED TO THE OVERHEATING CHARGER ISSUE. THE PATIENT WAS SENT A REPLACEMENT CHARGER AND NO FURTHER PROBLEMS HAVE BEEN ALLEGED. ONLINE PORTAL RECORDS SHOW THE DEVICE HAS SUCCESSFULLY TRANSMITTED BLOOD GLUCOSE LOGS FOLLOWING CHARGER REPLACEMENT. PRODUCT MANUFACTURING RECORDS WERE REVIEWED AND NO CONTRIBUTING FACTORS WERE FOUND. INITIAL INVESTIGATION FOUND THE OVERHEATING WAS LIKELY THE RESULT OF A SHORT IN THE CHARGER USB-C CONNECTOR. CHARGER WILL BE RETURNED TO THE ORIGINAL MANUFACTURING FACILITY FOR FURTHER INVESTIGATION AND TO CONFIRM THE SUSPECTED ROOT CAUSE.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THE CHARGER FOR THEIR BIOTEL BGM WOULD NOT CHARGE THEIR DEVICE. THERE WAS NO ALLEGATION OR EVIDENCE OF INJURY OR MEDICAL ATTENTION SOUGHT BY THE PATIENT, AND NO ADDITIONAL INFORMATION WAS PROVIDED. WHEN THE CHARGER WAS RETURNED FOR EVALUATION, THE PLASTIC ON THE USB-C CONNECTOR WAS FOUND TO BE MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304645 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown