BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7406979 · Received April 9, 2018

    Report

    Report Number
    1000113657-2018-00415
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 9, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00052569138526
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET 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 (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (DATE) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER WANTED TO SEND BACK THE NEW METER BUT I TOLD THE CUSTOMER THAT WE WILL NEED TO GET BACK THE OLD METER AND STRIPS AND TO KEEP THE NEW METER AND STRIPS. HE SAID THE OLD METER AND STRIPS ARE WORKING FINE BUT HE WILL SEND BACK THE OLD METER AND STRIPS. 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 FROM RESULTS OBTAINED OF 260, 190, 213, 237 AND 184 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 124-134 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH ERRATIC TEST RESULTS BUT RESULTS PROVIDED WERE NOT REPORTED AS BEING PERFORMED BACK TO BACK. 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 FASTING AND PRODUCED TEST RESULTS OF 238 MG/DL AND 244 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN CONCERNED WITH THE RESULTS HE RECEIVED FROM THE METER. CUSTOMER IS CONCERNED THAT THE METER KEEPS JUMPING FROM ON RESULTS TO ANOTHER WHEN HE TESTS ON HIS FOREARM. CUSTOMER STATES THAT THE RESULTS ARE ALMOST 100 POINTS DIFFERENT WHEN HE TOOK WITHIN 2 HOURS OF EACH OTHER. INFORMED CUSTOMER THAT RESULTS WHEN COMPARED BACK TO BACK SHOULD BE THEN WITHIN 30 MINUTES, TWO DIFFERENT FINGERS ON THE SAME HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251428 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2674 00052569138526

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR