BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3231764 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00123
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 3, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. CALLER STATES HER RESULTS ARE NORMALLY BETWEEN 80-90 MG/DL. CALLER PROVIDED PREVIOUS RESULTS FROM MEMORY. THE HIGHEST RESULT PROVIDED WAS 170 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327838 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RP4122

    Patients

    Seq Age Sex Outcome Treatment
    1