BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5224597 · Received November 15, 2015

    Report

    Report Number
    1052693-2015-02222
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    October 22, 2015
    Report Date
    November 13, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED AND EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES THAT SHE FEELS LIGHTHEADED BUT DENIES THE NEED OF MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90- 110MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 5/31/2016. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN STORED IN THE KITCHEN AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1: "LO" (B)(6) 2015 03:41:00 PM FASTING:YES. 2: "LO" (B)(6) 2015 03:28:00 PM FASTING:YES. 3: "LO" (B)(6) 2015 03:22:00 PM FASTING:YES. 4: "LO" (B)(6) 2015 03:07:00 PM FASTING:YES. MEMORY CONCERNS:"LO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754084 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1416

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR