BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6356368 · Received February 24, 2017

    Report

    Report Number
    1000113657-2017-00381
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 30, 2017
    Report Date
    February 24, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER INITIALLY REPORTED COMPLAINT FOR E-2 ERROR MESSAGE: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR MESSAGE HAD OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. WHILE TROUBLESHOOTING, THE CUSTOMER HAD PERFORMED A BLOOD TEST FASTING AND OBTAINED A RESULT OF 182 MG/DL USING TRUEMETRIX METER. THE CUSTOMER HAD STATED THE RESULT WAS TOO HIGH FOR HIM. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 130 MG/DL. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 182, 141 AND 142 MG/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. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 182 MG/DL 190 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED IN THE LIVING ROOM, IN ENCLOSED PLASTIC CONTAINER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(46.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139347 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2081 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY