BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 5569750 · Received April 12, 2016

    Report

    Report Number
    1052693-2016-00714
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 12, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS (MORE THAN 600MG/DL). CUSTOMER STATES THAT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 270-300MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 8/31/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2016. CUSTOMER PERFORMED A BLOOD TEST AND OBTAINED HI NOT FASTING. REVIEWED METER MEMORY: R-1-HI (B)(6) 2016 FASTING:NO, C-2-49MG/DL (B)(6) 2016 -CONTROL TEST, R-3-HI (B)(6) 2016 FASTING:NO, R-4-HI (B)(6) 2016 FASTING:NO, R-5-HI (B)(6) 2016 FASTING:NO, MEMORY CONCERNS: HI. CUSTOMER STATES GLUCOSE LEVELS ARE NORMALLY HIGH. CUSTOMER IS PERFORMING BLOOD TEST USING TWO TRUE2GO METERS R02980524 (STRIPS) (B)(4) (IN DATE) AND RESULTS WERE HI, COMPARED RESULTS WITH R03345967- STRIPS ((B)(4)) RESULTS HI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227689 TRUE2GO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUE2GO PS2486

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY