BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3382940 · Received September 4, 2013

    Report

    Report Number
    1052693-2013-00215
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    August 19, 2013
    Report Date
    September 3, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CUSTOMER STATES SHE IS USED TO RESULTS OF 140-200 MG/DL. REVIEWED METER MEMORY - 112, 172, 74, 74, 122, 144 MG/DL (NO DATE OR TIME RECORDED). CUSTOMER IS CONCERNED ABOUT RESULTS OF 112, 74 AND 114 OBTAINED 2 HOURS AFTER A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437808 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1167

    Patients

    Seq Age Sex Outcome Treatment
    1