BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 2081844 · Received April 5, 2011

    Report

    Report Number
    1052693-2011-00015
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 5, 2011
    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

    (B)(4). THE USER IS INSTRUCTED TO VERIFY THE CODE CHIP NUMBER WITH BOTH THE CODE NUMBER PRINTED ON THE TEST STRIP BOX AND THE CODE NUMBER APPEARING IN THE METER DISPLAY UPON INSERTION OF THE CODE CHIP INTO THE METER. THIS INSTRUCTION IS PROVIDED IN THE USER MANUAL. THE USER IS INSTRUCTED TO PERFORM THIS STEP PRIOR TO TESTING WITH THE DEVICE.

    Description of Event or Problem · 1

    PHARMACY CALLED THAT A CUSTOMER CLAIMED THE TEST STRIP BOX (100 CT) CONTAINED THE WRONG CODE CHIP SO THEY DID NOT WORK PROPERLY. CUSTOMER WENT TO THE DOCTOR FOR LOW BLOOD SUGAR. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RK3248

    Patients

    Seq Age Sex Outcome Treatment
    1