BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19076290 · Received April 9, 2024

    Report

    Report Number
    3008514395-2024-00006
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 6, 2024
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE ALLEGATION, A REVIEW OF READING LOGS TRANSMITTED BY THE AFFECTED DEVICE WAS PERFORMED. IT WAS CONFIRMED THAT ON THE DATE OF THE EVENT, ONE OUT-OF-RANGE L2 TEST RESULT WAS LOGGED BY THE DEVICE. NO EVIDENCE OF BACK-TO-BACK READINGS MORE THAN 15% APART AND NO OTHER OUT-OF-RANGE CONTROL SOLUTION TEST RESULTS WERE FOUND. THOUGH THE OUT-OF-RANGE RESULT MAY HAVE BEEN CAUSED BY FACTORS OTHER THAN DEVICE MALFUNCTION (E.G. USER ERROR BY INCORRECTLY APPLYING CONTROL SOLUTION), THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT WAS CONTACTED MULTIPLE TIMES AFTER THE EVENT TO REQUEST ADDITIONAL INFORMATION AND THE RETURN OF THE AFFECTED DEVICE. TO DATE, THE PATIENT HAS NOT RESPONDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. NO EXTERNAL DEVICE DAMAGE WAS IDENTIFIED. CONTROL SOLUTION TESTING WAS PERFORMED USING CONTROL SOLUTION AND TEST STRIPS. NO DEVICE INACCURACY WAS IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER WAS NOT ACCURATE AFTER COMPARING RESULTS WITH A METER FROM A DIFFERENT MANUFACTURER. THE PATIENT PERFORMED CONTROL SOLUTION TESTS ON THE DEVICE AND ALLEGED THAT ONE L1 TEST RESULT AND ONE L2 TEST RESULT WAS OUTSIDE THE SPECIFIED RANGE. THERE WAS NO ALLEGATION OF SYMPTOMS OR INJURY ASSOCIATED WITH THE EVENT AND NO TREATMENT OR MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455884 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown