BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5099087 · Received September 23, 2015

    Report

    Report Number
    1052693-2015-01787
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 ERRATIC RESULTS. CUSTOMER STATES HE FEELS WELL AND STATES HE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-120MG/DL. VERIFIED THE STRIPS EXPIRE 07/31/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST 86MG/DL AND 108MG/DL FASTING. REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN:CUSTOMER IS CALLING CONCERN WITH ALL THE RESULTS THAT WERE TAKEN ON (B)(6) 2015 95/115/178 MG/DL THAT WAS TAKEN A FEW MINUTES APART. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627474 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2438

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY