BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4451491 · Received January 22, 2015

    Report

    Report Number
    1052693-2015-00044
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 27, 2014
    Report Date
    January 9, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATION RESULTED IN NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD A TEST STRIP ISSUE, USER HAD A HIGH GLUCOSE RESULT.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". EXPECTED BLOOD GLUCOSE RANGE IS 125MG/DL-140MG/DL, BEFORE EATING. PERFORMED A BLOOD TEST IN THE MORNING AND RECEIVED A 235MG/DL, FASTING. PERFORMED A BACK TO BACK BLOOD TEST; HI AND 600 MG/DL, 2 HOURS AFTER EATING. PERFORMED A BLOOD TEST ON ANOTHER LOT OF TEST STRIPS, RESULT WAS HI. REVIEWED THE LAST FIVE BLOOD RESULTS FROM THE METER MEMORY: 1) HI, (B)(6), 4:04 PM, 2 HOURS AFTER EATING 2) HI, (B)(6), 4:02 PM, 2 HOURS AFTER EATING 3) 235 MG/DL, (B)(6), 6:40 AM, BEFORE EATING 4) 371 MG/DL , (B)(6), 8:48 PM, LESS THAN 2 HOURS AFTER EATING 5) 284 MG/DL, (B)(6), 5:24 AM, BEFORE EATING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53425 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1969

    Patients

    Seq Age Sex Outcome Treatment
    1