BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23228007 · Received October 6, 2025

    Report

    Report Number
    3008514395-2025-00007
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 3, 2025
    Report Date
    March 24, 2026
    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

    THE DEVICE WAS RETURNED TO A PHILIPS FACILITY FOR EVALUATION. ALLEGATION THAT DEVICE BATTERY BURST WAS NOT CONFIRMED AS INITIAL INSPECTION OF THE AFFECTED DEVICE FOUND THAT THE BATTERY WAS INTACT AND FUNCTIONAL. THOUGH INITIAL INSPECTION FOUND NO EVIDENCE OF THE ALLEGED BATTERY RUPTURE, IT WAS UNABLE TO RULE OUT BATTERY FLUID LEAKAGE AS THERE WAS UNKNOWN WHITE AND BLUE RESIDUE IN THE BATTERY COMPARTMENT, BATTERY CONTACT PLATE DISCOLORATION, AND UNEXPECTED BROWN STAINING NEAR THE BATTERY MOISTURE DETECTION STICKER. INVESTIGATION IS NOT YET COMPLETE AS ADDITIONAL EVALUATION IS REQUIRED. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT CASE BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 0

    CASE WAS INITIALLY REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO ALLEGATION THAT THE DEVICE BATTERY BURST. EVALUATION OF THE AFFECTED DEVICE FOUND THAT THE BATTERY HAD EVIDENCE OF WATER EXPOSURE BUT WAS INTACT AND FUNCTIONAL. DEVICE AND BATTERY WERE SENT TO THE ORIGINAL MANUFACTURER FOR FURTHER ANALYSIS. MANUFACTURER EVALUATION WAS UNABLE TO CONFIRM THE ALLEGATION THAT THE BATTERY BURST AND FOUND NO EVIDENCE OF BATTERY FLUID LEAKAGE. IT WAS CONFIRMED THAT THE DEVICE HAD BEEN DAMAGED BY INGRESS OF WATER LEADING TO CORROSION AT THE BATTERY CONTACT PINS. WATER DAMAGE IS ATTRIBUTED TO USER ERROR AS PRODUCT USER MANUAL PROVIDED WITH THE DEVICE INSTRUCTS USERS TO AVOID LETTING THE DEVICE COME IN CONTACT WITH WATER.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THEIR PHILIPS CONNECTED BLOOD GLUCOSE METER WOULD NOT TURN ON. WHEN THEY REMOVED THE BATTERY TO RESET THE DEVICE, THEY ALLEGED THAT THE BATTERY APPEARED TO BE BURST AND WAS LEAKING BLUE LIQUID. THE PATIENT STATED THEY CLEANED THE BLUE LIQUID OFF OF THE BATTERY BUT DID NOT MAKE PHYSICAL CONTACT WITH THE FLUID. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420752 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female