BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5151637 · Received October 15, 2015

    Report

    Report Number
    1052693-2015-02003
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 14, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 "LO" RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-105MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 01/14/2018. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE WAS (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST LO ON BOTH TESTS. REVIEWED METER MEMORY 1: LO FASTING: YES, 2: 32 MG/DL FASTING: YES, 3: 57MG/DL FASTING: YES, 4: 105MG/DL FASTING: YES, 5: LO FASTING: YES. CUSTOMERS CONCERN: LO, 32, 57, LO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684568 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2193

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY