BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3036867 · Received March 29, 2013

    Report

    Report Number
    1052693-2013-00033
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 29, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH CONTROL RESULTS. CONTROL TEST RESULTS WERE 231 MG/DL AND 241 MG/DL FOR A CONTROL RANGE OF 153-207 MG/DL. CONTROL TEST RESULT WAS 218 MG/DL USING A SECOND VIAL OF STRIPS FROM THE SAME LOT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131316 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RN4068

    Patients

    Seq Age Sex Outcome Treatment
    1