BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231753 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00127
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TEST RESULTS WERE 118 MG/DL, 194 MG/DL, 238 MG/DL AND 115 MG/DL. NO ADVERSE EVENT REPORTED. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THESE TWO RESULTS IS IN ZONE C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325842 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1133

    Patients

    Seq Age Sex Outcome Treatment
    1