BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7903767 · Received September 24, 2018

    Report

    Report Number
    1000113657-2018-00971
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 31, 2018
    Report Date
    September 24, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292001018
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 UDI# (B)(4). NOTE: AFTER SEVERAL ATTEMPTS MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER STATED THAT HAD NO TIME TO SPEAK TO US AND WILL CALL BACK WHEN SHE HAS TIME.

    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 212, 219, 181, 238 AND 240 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 180 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING ILL AND HAD SYMPTOMS OF FATIGUE AND BLURRED VISION. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/26/2020 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
    742690 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5251 00021292001018

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR