BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 3231774 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00133
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 15, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 ABOUT HIGH BLOOD RESULTS. MEMORY RESULTS 177MG/DL 2 HOURS AFTER BREAKFAST, 186MG/DL 2 HOURS AFTER BREAKFAST, 381MG/DL 2 HOURS AFTER DINNER, 95MG/DL FASTING. COMPETITOR'S METER READING 120MG/DL COMPARED TO TRUEBALANCE 303MG/DL 2 HOURS AFTER BREAKFAST. CALLER STATES HE NORMALLY RANGES FROM 115-120MG/DL. THERE IS ONE RESULT IN MEMORY THAT READS LO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326767 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BP4096

    Patients

    Seq Age Sex Outcome Treatment
    1