BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7158080 · Received January 2, 2018

    Report

    Report Number
    1000113657-2018-00007
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 2, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292008642
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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-20-USER'S TEST STRIP HAD POOR STORAGE.(KITCHEN) TEST STRIP (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 35 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 250 MG/DL; THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 251 - 400 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF FREQUENT URINATION, THIRST AND INCREASED APPETITE. CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING LOW. CUSTOMER STATES THE METER READ 35 MG/DL FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5068 00021292008642

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR