BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5128335 · Received October 5, 2015

    Report

    Report Number
    1052693-2015-01897
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 5, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES SHE FEELS WELL AND DOES NOT REQUIRE ANY MEDICAL ATTENTION AT THIS TIME. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 160-200MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 07/19/2017. CUSTOMER CONFIRMS THE STRIPS WERE FIRST OPENED (B)(6) 2015 AND HAVE BEEN STORED PROPERLY. REVIEWED METER MEMORY 1:LO (B)(6) 2015 08:23:00 AM FASTING:YES; 2:LO (B)(6) 2015 08:34:00 AM FASTING:YES; 3:LO (B)(6) 2015 08:33:00 AM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657945 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2041

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR