BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9395909 · Received December 2, 2019

    Report

    Report Number
    1000113657-2019-10193
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 2, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 183, 242 AND 255 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 120 MG/DL; DAUGHTER STATED THIS IS THE RANGE ENDOCRINOLOGIST WANTS CUSTOMER BLOOD GLUCOSE TO BE. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE AND WAS USING ALCOHOL ON FINGERS PRIOR TO TESTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2020 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191496 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MV2947 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1