BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8051451 · Received November 8, 2018

    Report

    Report Number
    1000113657-2018-01144
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 8, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55-USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 196, 180, 213, 132, 181, 133, 187 AND 94 MG/DL. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 107 - 121 MG/DL. THE CUSTOMER ALSO STATED THAT WHEN THEY COMPARE THEIR RESULTS FROM THE TRUEMETRIX METER TO ANOTHER DEVICE, THE TRUE METRIX METER IS READING HIGHER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-2 AND E-2 USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/20/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891530 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2790 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR