BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7843879 · Received September 4, 2018

    Report

    Report Number
    1000113657-2018-00922
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 4, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 8/20/2018 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 FROM RESULTS OBTAINED OF 161, 138, 127 AND 125 MG/DL. CUSTOMER STATED SHE NOTICED THE HIGH RESULTS SINCE (B)(6) 2018, WHEN SHE GOT A NEW VIAL OF TEST STRIPS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 MG/DL. 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 OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683491 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5210

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR