BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3802524 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00129
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 24, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT LOW BLOOD RESULTS. CUSTOMER'S DAUGHTER STATED HER FATHER TOLD HER HE HAD GONE FOR A WALK AND FELT DIZZY. WHEN HE GOT HOME HE TESTED AND RECEIVED A "LO" RESULT AND STILL WAS NOT FEELING WELL. SHE INSTRUCTED HIM TO EAT A PEANUT BUTTER SANDWICH TO BRING HIS GLUCOSE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111664 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other