BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5189443 · Received October 29, 2015

    Report

    Report Number
    1052693-2015-02121
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 29, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF "LO" RESULTS. CUSTOMER STATES SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-140MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST LO AND LO FASTING. REVIEWED METER MEMORY: 1:LO- FASTING:YES. 2:LO- FASTING:YES. 3:LO- FASTING:YES. 4:LO- FASTING:YES. 5:LO- FASTING:YES. THE CUSTOMER DATE AND TIME IS INCORRECT. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717182 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1743

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR