BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3303583 · Received August 14, 2013

    Report

    Report Number
    1052693-2013-00188
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 13, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. LOWEST RESULT IN MEMORY WAS (B)(6) AT 1:22P OF 56MG/DL. CALLER STATES HIS GLUCOSE IS NORMALLY 100-110MG/DL. NO ADVERSE EVENT REPORTED. OTHER MEMORY RESULTS: (B)(6) AT 11:34A 64MG/DL, (B)(6) AT 7:29A 64MG/DL, (B)(6) AT 5:34A 82MG/DL, (B)(6) AT 8:56P 60MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388950 TRUERESULT BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUERESULT PP1156

    Patients

    Seq Age Sex Outcome Treatment
    1