BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19934584 · Received August 7, 2024

    Report

    Report Number
    3008514395-2024-00007
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 7, 2024
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE ALLEGED EVENT, THE PATIENT CALLED CUSTOMER SUPPORT. CUSTOMER SUPPORT ATTEMPTED TO PERFORM TROUBLESHOOTING AND RUN CONTROL SOLUTION TESTS VIA TELEPHONE WITH THE PATIENT, BUT THE PATIENT REFUSED TROUBLESHOOTING AND REQUESTED A REPLACEMENT DEVICE. A REVIEW OF READING LOGS TRANSMITTED BY THE AFFECTED DEVICE WAS PERFORMED. DEVICE RECORDS SHOWED THREE L1 CONTROL SOLUTION TESTS AND ZERO L2 CONTROL SOLUTION TESTS LOGGED BY THE METER. ALL L1 CONTROL SOLUTION TEST RESULTS WERE WITHIN THE SPECIFIED RANGE. NO EVIDENCE OF BACK-TO-BACK READINGS MORE THAN 15% APART ON THE AFFECTED DEVICE WAS FOUND. DEVICE RECORDS SHOW PATIENT BLOOD GLUCOSE LEVELS WERE FREQUENTLY IN THE 300S AND 400S. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT THE DEVICE FUNCTIONED PER SPECIFICATION AND AS INTENDED BY ALERTING THE PATIENT TO ELEVATED BLOOD GLUCOSE LEVELS. THOUGH THERE IS NO EVIDENCE OR ALLEGATION OF HEALTH IMPACT TO THE PATIENT, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE PATIENT CALLING 911 AND RECEIVING EMERGENCY MEDICAL ASSISTANCE. THE PATIENT WAS CONTACTED MORE THAN THREE (3) TIMES AFTER THE EVENT TO REQUEST ADDITIONAL INFORMATION AND RETURN OF THE AFFECTED DEVICE. TO DATE, THE PATIENT HAS NOT RESPONDED, AND THE AFFECTED DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 0

    THE PATIENT CALLED 911 AFTER RECEIVING A VERY HIGH RESULT ON THEIR BLOOD GLUCOSE METER. WHEN THE PARAMEDICS ARRIVED AT THE PATIENT'S HOME, THEY TESTED THE PATIENT'S BLOOD GLUCOSE WITH A DIFFERENT DEVICE AND RECEIVED A RESULT 60 POINTS LOWER THAN THAT RETURNED BY THE PATIENT'S METER. THE PATIENT DID NOT INDICATE WHETHER THE COMPARED READINGS WERE TAKEN WITHIN 15 MINUTES OF ONE ANOTHER AND THE SPECIFIC VALUES OF THE COMPARED RESULTS WERE NOT PROVIDED. THE PATIENT DID NOT INDICATE WHETHER THEY PERFORMED CONTROL SOLUTION TESTS ON THEIR METER TO VERIFY DEVICE. THE PATIENT DID NOT ALLEGE INJURY AND DID NOT PROVIDE SPECIFIC DETAILS REGARDING ASSISTANCE PROVIDED BY PARAMEDICS OR WHETHER TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402744 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown