BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUEBALANCE

    MDR report key: 3210805 · Received July 2, 2013

    Report

    Report Number
    1052693-2013-00103
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    March 19, 2013
    Report Date
    June 18, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT INVESTIGATION IS COMPLETED. BLOOD TESTING DEMONSTRATES THAT THE DEVICE PERFORMS WITHIN SPECIFICATIONS. CONTROL SOLUTION TEST PERFORMED BY USER WAS IN RANGE. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS TEST STRIP LOT. (B)(4). WE ACKNOWLEDGE THE LATENESS OF THIS REPORT AND ARE TAKING CORRECTIVE ACTION INTERNALLY. MANUFACTURER'S NUMBER IS CORRECTED.

    Description of Event or Problem · 1

    DAUGHTER OF PATIENT CALLED PARAMEDICS BECAUSE THE METER DISPLAYED A BLOOD GLUCOSE RESULT OF HI. PATIENT WAS UNRESPONSIVE WHEN THE PARAMEDICS CAME. PARAMEDICS TESTED THE PATIENTS BLOOD AND THE RESULT WAS LO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302388 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BN063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other