BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 20049889 · Received August 23, 2024

    Report

    Report Number
    3008514395-2024-00008
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 25, 2024
    Report Date
    February 24, 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

    THE PATIENT CONTACTED CUSTOMER SUPPORT DUE TO DIFFICULTY POWERING ON THEIR BLOOD GLUCOSE METER. TROUBLESHOOTING WAS PERFORMED VIA TELEPHONE AND A FAULTY CHARGER WAS FOUND TO BE THE LIKELY CAUSE OF THE ALLEGED ISSUE. A REPLACEMENT CHARGER WAS ISSUED AND ONLY THE SUSPECTED CHARGER WAS RETURNED TO PHILIPS FOR EVALUATION. INSPECTION OF THE RETURNED CHARGER FOUND THE PLASTIC AND ADHESIVE NEAR THE USB-C CONNECTOR HAD MELTED. THE CHARGER WOULD NOT FIT INTO A KNOWN FUNCTIONAL METER DUE TO MELTED ADHESIVE COVERING THE USB-C CONNECTOR. TESTING OF THE SUSPECTED CHARGER CONFIRMED THAT WHEN CONNECTED TO A POWER SOURCE, THE USB-C CONNECTOR QUICKLY REACHED ELEVATED TEMPERATURES. THE CHARGER WILL BE SENT TO VENDOR FOR FURTHER ANALYSIS TO DETERMINE ROOT CAUSE OF THE CHARGER FAILURE. AFTER SHIPMENT OF THE REPLACEMENT CHARGER, A FOLLOW-UP CALL WAS MADE TO THE PATIENT. TO DATE, THE PATIENT HAS NOT RESPONDED OR CONTACTED CUSTOMER SUPPORT FOR FURTHER INQUIRIES. READING TRANSMISSION RECORDS FOR THE AFFECTED BLOOD GLUCOSE METER SHOW DAILY TRANSMISSION OF NEW TEST RESULTS FOLLOWING DELIVERY OF THE REPLACEMENT CHARGER. THIS DEMONSTRATES THAT THE DEVICE SUCCESSFULLY CHARGES AND POWERS ON WHEN CONNECTED TO A DIFFERENT CHARGER WITH NO INDICATION OF DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE AFFECTED CHARGER WAS SENT TO VENDOR FOR ADDITIONAL ROOT CAUSE ANALYSIS. VENDOR INVESTIGATION CONCLUDED THAT EXCESSIVE HEATING OF THE USB-C CONNECTOR WAS CAUSED BY LIQUID SPILLED INTO THE CONNECTOR AND IS ATTRIBUTED TO END-USER MISUSE.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER WOULD NOT CHARGE, AND THAT THE CHARGER GOT HOT WHILE PLUGGED IN. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT AND NO INJURY OR PROPERTY DAMAGE WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582047 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown