BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4223591 · Received August 5, 2014

    Report

    Report Number
    1052693-2014-00241
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    February 4, 2014
    Report Date
    August 4, 2014
    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

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4). WE APOLOGIZED FOR THE LATENESS OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT THE RESULTS ARE CONSISTENTLY "LO". NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458635 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PP1106

    Patients

    Seq Age Sex Outcome Treatment
    1