BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUBALANCE

    MDR report key: 5810262 · Received July 20, 2016

    Report

    Report Number
    1052693-2016-01235
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 20, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. CUSTOMER RETURNED ONE TEST STRIP ONLY - UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 TO 100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/18/2018. PRODUCT IS STORED ACCORDING TO SPECIFICATION. REVIEW METER MEMORY: TRUE BALANCE 128, (B)(6) 2016 07:00:00 AM, FASTING. TRUE BALANCE 187, (B)(6) 2016 07:00:00 AM, FASTING. TRUE BALANCE 126, (B)(6) 2016 07:00:00 AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462944 TRUBALANCE BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUBALANCE BT4861

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR