BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7868340 · Received September 12, 2018

    Report

    Report Number
    1000113657-2018-00941
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 17, 2018
    Report Date
    September 12, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 240, 173, 270, 164 AND 224 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120MG/DL 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 201 MG/DL AND 186 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/26/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711731 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2764 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY