BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5326931 · Received December 24, 2015

    Report

    Report Number
    1052693-2015-02569
    Event Type
    Malfunction
    Date Received
    December 24, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 2, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: STRIP ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION TODAY (B)(6) 2015. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 150-200MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 11/30/2017. 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 555MG/DL AND 425MG/DL FASTING. REVIEWED METER MEMORY. 308MG/DL, (B)(6) 2015 09:40:00 PM, FASTING:YES. 313MG/DL, (B)(6) 2015 09:39:00 PM, FASTING:YES. 314MG/DL, (B)(6) 2015 09:24:00 PM, FASTING:YES. 300MG/DL, (B)(6) 2015 09:22:00 PM, FASTING:YES. LO, (B)(6) 2015 09:18:00 PM, FASTING:YES. MEMORY CONCERNS:LO. CUSTOMER STATES THAT YESTERDAY (B)(6) 2015 HE DID EXPERIENCE SYMPTOMS OF LOW SUGAR SUCH AS DIZZINESS, SWEATING, FEELING OF WEAKNESS. CUSTOMER WAS ADVISED SHOULD HE EXPERIENCE THOSE SYMPTOMS AGAIN TO SEEK MEDICAL ATTENTION ASAP. CUSTOMER STATED THE METER DOES NOT HAVE THE CORRECT DAY AND TIME SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851379 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2175

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR