BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4844488 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00894
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT YET RETURNED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT #:(B)(4). PRODUCT NOT RETURNED FOR EVAL. MOST LIKELY UNDERLYING ROOT CAUSE IS: USER HAS HIGH GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI." CUSTOMER STATES THAT SHE HAS SYMPTOMS OF HYPERGLYCEMIA AT THIS TIME, SUCH AS DRY MOUTH AND THIRST. IT WAS RECOMMENDED TO THE CUSTOMER TO SEEK MEDICAL ATTENTION. CUSTOMER STATED SHE MAY CONSULT HER DOCTOR FOR FURTHER ASSISTANCE. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-200MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2016. CUSTOMER WAS UNABLE TO CONFIRM STORAGE CONDITIONS OR WHEN THE TEST STRIP VIAL WAS OPENED. REVIEWED METER MEMORY: 1: UNDISCLOSED 2: UNDISCLOSED 3: UNDISCLOSED 4: UNDISCLOSED 5: UNDISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380847 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BR4454

    Patients

    Seq Age Sex Outcome Treatment
    1