BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 5896513 · Received August 23, 2016

    Report

    Report Number
    1000113657-2016-01391
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    July 27, 2016
    Report Date
    August 23, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. 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 IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 194, 184, 143, 154 AND 198 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2017 AND OPEN VIAL DATE IS (B)(4) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER STATED IS TESTING SEVEN TIMES A DAY (FASTING) . THE CUSTOMER HAS RECENTLY MADE CHANGES IN THE MEDICATION BUT NO CHANGES IN THE DIET OR EXERCISE REGIMEN. THE CUSTOMER STATED THAT THE METER WOULD NOT TURN ON TO RETRIEVE THE RESULTS FROM THE METER'S MEMORY (METER DEAD) BUT HAS PROVIDED THE RESULTS FROM THE DAILY LOG BOOK. UNABLE TO PERFORM A BACK TO BACK BLOOD TESTS DUE TO THE METER IS DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548122 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1519

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY