BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 3287430 · Received August 6, 2013

    Report

    Report Number
    1052693-2013-00161
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 27, 2013
    Report Date
    August 5, 2013
    Manufacturer
    NIPRO DIAGNSOTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LOW BLOOD GLUCOSE RESULTS. RESULTS FROM MEMORY ARE AS FOLLOWS: (B)(6) 2013 AT 5:26P 27MG/DL, (B)(6) 2013 AT 4:38P 28MG/DL, (B)(6) 2013 AT 4:37P 131MG/DL, (B)(6) 2013 AT 2:28P 28MG/DL. CALLER STATES HIS GLUCOSE IS NORMALLY 90MG/DL - 112MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368964 TRUE RESULT BLOOD GLOCUSE SYSTEM CGA NIPRO DIAGNSOTICS, INC. TRUE RESULT PP1367

    Patients

    Seq Age Sex Outcome Treatment
    1