BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3252480 · Received July 24, 2013

    Report

    Report Number
    1052693-2013-00146
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 24, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 IN MEMORY INDICATED A RESULT OF 65MG/DL ON (B)(6) AT 9:23A (FASTING). CALLER STATES GLUCOSE IS NORMALLY 118MG/DL - 125MG/DL FASTING AND 145-153MG/DL 2 HOURS AFTER EATING LUNCH OR DINNER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344732 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1201

    Patients

    Seq Age Sex Outcome Treatment
    1