BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7932098 · Received October 3, 2018

    Report

    Report Number
    1000113657-2018-00997
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 3, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00050428264706
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55-USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM. (B)(4). MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    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 186, 190, 165, 199 AND 257 MG/DL. CUSTOMER ALSO STATED THAT THE TRUETRACK METER IS READING 30 POINTS HIGHER THAN HIS DOCTORS HANDHELD METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 140 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. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/16/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :186MG/DL DATE: (B)(6) 2018 TIME:09:41AM FASTING; RESULT 2 :190MG/DL DATE: (B)(6) 2018 TIME:06:30AM FASTING; RESULT 3 :165MG/DL DATE: (B)(6) 2018 TIME:11:30AM FASTING; RESULT 4 :199MG/DL DATE: (B)(6) 2018 TIME:07:18AM FASTING; RESULT 5 :257MG/DL DATE: (B)(6) 2018 TIME:02:53PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770957 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5152 00050428264706

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR