BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702032 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00523
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS RETURNED WERE EXPIRED. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 108-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 03/18/2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. REVIEWED METER MEMORY: 88MG/DL; (B)(6) 2015; 07:32:07 PM; FASTING: NO, 140MG/DL; (B)(6) 2015; 07:32:07 PM; FASTING: NO, LO; (B)(6) 2015; 07:32:07 PM; FASTING: NO, 93MG/DL; (B)(6) 2015; 07:32:07 PM; FASTING: NO, 107MG/DL; (B)(6) 2015; 07:32:07 PM; FASTING: NO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252720 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT TN2707

    Patients

    Seq Age Sex Outcome Treatment
    1