BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMETRXGO

    MDR report key: 6522322 · Received April 26, 2017

    Report

    Report Number
    1000113657-2017-00736
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    April 1, 2017
    Report Date
    April 26, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007706
    PMA / PMN Number
    K143548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 152, 122 AND 152 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 110 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER HAD EATEN AND DRANK COFFEE LESS THAN 30 MINUTES PRIOR. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/26/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER STATED SHE TAKES HER BLOOD TEST FASTING AND SHE HAS NOT HAD CHANGES IN HER DIET AND EXERCISE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (MEMORY CONCERNS:THE CUSTOMER IS CONCERNED WITH THE 5 RESULTS PROVIDED IN THE METER'S MEMORY: (B)(6). MEMORY CONCERNS:THE CUSTOMER IS CONCERNED WITH THE 5 RESULTS PROVIDED IN THE METER'S MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303001 TRUMETRXGO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUMETRXGO MT2010 00021292007706

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY