BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5279146 · Received December 9, 2015

    Report

    Report Number
    1052693-2015-02406
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 11, 2015
    Report Date
    December 9, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PRODUCT RETURNED AND EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: STRIP ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 179-189MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 5/31/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST AND OBTAINED 586MG/DL AND HI FASTING. REVIEWED METER MEMORY: 1:HI (B)(6) 2015 01:42:00 PM FASTING:YES. 2:HI (B)(6) 2015 01:39:00 PM FASTING:YES. 3:HI L (B)(6) 2015 12:14:00 PM FASTING:YES. 4:HI (B)(6) 2015 12:13:00 PM FASTING:YES. 5:HI (B)(6) 2015 12:12:00 PM FASTING:YES. CUSTOMER IS CONCERN WITH ALL THE HI BLOOD RESULTS SHE IS GETTING. CUSTOMER STATES THAT SHE IS FEELING FINE SHE FEELS NORMAL. CUSTOMER STATES THAT SHE WAS AT HER DR. OFFICE YESTERDAY AND EVERYTHING WAS FINE BUT THEY CHANGE HER MEDICINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808748 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2356

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR