BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3303605 · Received August 14, 2013

    Report

    Report Number
    1052693-2013-00185
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 13, 2013
    Manufacturer
    NIPRO DIAGONOSTICS, INC
    Product Code
    CGA
    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 EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. RESULTS IN MEMORY INDICATED A RESULT OF 75MG/DL. CALLER STATES HIS GLUCOSE IS NORMALLY 130-140MG/DL. NO ADVERSE EVENT REPORTED. OTHER MEMORY RESULTS: 95MG/DL, 98MG/DL, 79MG/DL, 112MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389195 TRUERESULT BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGONOSTICS, INC TRUERESULT PP1221

    Patients

    Seq Age Sex Outcome Treatment
    1