BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3287491 · Received August 6, 2013

    Report

    Report Number
    1052693-2013-00171
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 5, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    CGA
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 AS FOLLOWS: 22MG/DL, 23MG/DL, 26MG/DL, 99MG/DL, AND 62MG/DL . CALLER STATES FASTING READINGS ARE NORMALLY 62-95MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368912 TRUERESULT BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC TRUERESULT PP1221

    Patients

    Seq Age Sex Outcome Treatment
    1