BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4432587 · Received January 15, 2015

    Report

    Report Number
    1052693-2015-00025
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 5, 2015
    Manufacturer
    NIPRO DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATION SHOWED NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE, USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF HIGH BLOOD RESULTS. PERFORMED BACK TO BACK BLOOD TEST, 330MG/DL-(THE CUSTOMER ATE OBER 2 HOURS AGO). EXPECTED BLOOD GLUCOSE RANGE IS 130MG/DL-140ML/GL, BEFORE EATING. REVIEWED THE LAST FIVE BLOOD RESULTS FORM THE METER MEMORY: (THE TIME IS NOT SET); 288MG/DL, 12-16, 11:50 AM, +2 HOURS AFTER EATING; 227MG/DL, 12-16, 6:45AM, BEFORE EATING; 152MG/DL, 12-11, 9:30, 2 HOURS AFTER EATING; 180MG/DL, 12-10, 10:30AM, 2 HOURS AFTER EATING; 135MG/DL, 12-08, 2 HOURS AFTER EATING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37075 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS TRUETRACK RR4493

    Patients

    Seq Age Sex Outcome Treatment
    1