BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5048254 · Received September 1, 2015

    Report

    Report Number
    1052693-2015-01581
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 8, 2015
    Report Date
    September 1, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS. CUSTOMER'S WIFE STATES THAT HER HUSBAND FEELS WELL AND STATES HE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/16/2018. CUSTOMER STATES THE STRIPS ARE PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST AND OBTAINED HI AND HI. REVIEWED METER MEMORY: 1: HI (B)(6) 2015 11:51:00 PM FASTING:NO; 2: HI (B)(6) 2015 10:49:00 AM FASTING:YES; 3: HI (B)(6) 2015 09:24:00 AM FASTING:YES; 4: HI (B)(6) 2015 09:07:00 AM FASTING:YES. CUSTOMER IS CONCERNED WITH ALL THE RESULTS THAT SAY HI ARE REASON OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578446 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2283

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR