BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3287493 · Received August 6, 2013

    Report

    Report Number
    1052693-2013-00166
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 25, 2013
    Report Date
    May 5, 2013
    Manufacturer
    NIPRO DIAGNOSITCS, INC
    Product Code
    CGA
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. PERFORMED BACK TO BACK BLOOD TESTS - 87MG/DL AND 87MG/DL. RESULTS FROM MEMORY ARE AS FOLLOWS: 98MG/DL (B)(6) AT 9:47A AND , 42MG/DL (B)(6) AT 12:11A. CALLER STATES HIS BLOOD GLUCOSE IS NORMALLY 100-110MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369248 TRUERESULT BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSITCS, INC TRUERESULT PP1363

    Patients

    Seq Age Sex Outcome Treatment
    1