BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231761 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00137
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 15, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC RESULTS. RESULTS FROM MEMORY WERE 139 MG/DL ON (B)(6) AT 12:51 P AND 518 MG/DL ON (B)(6) AT 12:50 P. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327806 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT RN3976

    Patients

    Seq Age Sex Outcome Treatment
    1