BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMETRIX PR

    MDR report key: 8021774 · Received October 30, 2018

    Report

    Report Number
    1000113657-2018-01119
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 12, 2018
    Report Date
    October 30, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006099
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM. TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 10/15/2018 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. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 252, 364, 219, 222 AND 220 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 160 MG/DL THE CUSTOMER IS USING TRUEMETRIX PRO METER; CUSTOMER WAS INFORMED THAT METER IS FOR MULTI PATIENT USE AND WILL REPLACE WITH TRUEMETRIX METER. 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/20/2020 AND OPEN VIAL DATE IS 10/10/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861836 TMETRIX PR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TMETRIX PR MV2933 00021292006099

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR