BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231781 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00131
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 11, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. RESULTS FROM MEMORY WERE 99MG/DL, 106MG/DL, 105 MG/DL. CALLER STATES HIS GLUCOSE IS NORMALLY 115MG/DL - 120MG/DL FASTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325953 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1285

    Patients

    Seq Age Sex Outcome Treatment
    1