BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23228783 · Received October 6, 2025

    Report

    Report Number
    3008514395-2025-00008
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 12, 2025
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CASE WAS INITIALLY REPORTED OUT OF AN ABUNDANCE OF CAUTION BASED ON THE ALLEGED MALFUNCTION. RETURN EVALUATION OF THE DEVICE WAS UNABLE TO CONFIRM THE ALLEGATION OF EXCESSIVE HEATING AS NO EVIDENCE OF EXCESSIVE HEATING WAS FOUND AND TESTING OF THE AFFECTED DEVICE AND CHARGER DEMONSTRATED THEY A SAFE TEMPERATURE WHILE CHARGING. THE USB CONNECTOR (CONNECTS TO AC WALL ADAPTER) OF THE RETURNED CHARGER WAS FOUND TO HAVE INDENTATIONS AND TEARS INDICATIVE OF DAMAGE CAUSED BY AN EXTERNAL FORCE. INVESTIGATION CONCLUDED NO DEVICE MALFUNCTION OCCURRED AND THE ALLEGED "MELTING" OF THE CHARGER WAS ATTRIBUTED TO DAMAGE CAUSED BY IMPROPER STORAGE/USE LEADING TO DAMAGE FROM EXTERNAL FORCES.

    Additional Manufacturer Narrative · 0

    CASE WAS DETERMINED TO BE REPORTABLE BASED ON THE ALLEGED MALFUNCTION. THE AFFECTED DEVICE AND CHARGER HAVE BEEN RETURNED TO PHILIPS FOR EVALUATION AND INVESTIGATION IS IN PROCESS BUT HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7007 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male