BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5274768 · Received December 8, 2015

    Report

    Report Number
    1052693-2015-02391
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    November 10, 2015
    Report Date
    December 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 160-170MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 5/16/2017. 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 LO AND LO NOT FASTING. REVIEWED METER MEMORY: 1:165MG/DL (B)(6) 2015 02:44:00 PM FASTING:NO. 2:LOL (B)(6) 2015 02:31:00 PM FASTING:NO. 3:LOL (B)(6) 2015 02:27:00 PM FASTING:NO. 4:LOL (B)(6) 2015 02:26:00 PM FASTING:NO. 5:168MG/DL (B)(6) 2015 11:42:00 AM FASTING:YES. MEMORY CONCERNS:LO (B)(6) 2:31PM, LO (B)(6) 02:27PM, AND LO (B)(6) 02:26PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805871 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1965

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR