BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3802507 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00136
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 18, 2015
    Report Date
    February 13, 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 DETECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION NOTED IN THE COMPLAINT: USER HAS LOW GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". REVIEWED THE LAST 5 RESULTS IN THE METER MEMORY: (B)(6) 2015 - 12:18AM - LO, (B)(6) 2015 - 09:56P, - 121, (B)(6) 2015 - 07:51PM - 167, (B)(6) 2015 - 04:53PM - 234, (B)(6) 2015 - 1:31PM - 167. CUSTOMER IS FEELING WELL AT THIS TIME AND DOES NOT REQUIRE ANY MEDICAL ATTENTION. CUSTOMER DOES NOT HAVE THE TEST STRIPS AVAILABLE AND UNABLE TO RUN ANY BLOOD TEST. CUSTOMER STORES STRIPS IN THE KITCHEN. CUSTOMER DOES NOT KNOW HIS EXPECTED RANGE SINCE HE WAS RECENTLY DIAGNOSED AND THE DR. DID NOT GIVE HIM A SPECIFIC RANGE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111637 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1