BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7108117 · Received December 12, 2017

    Report

    Report Number
    1000113657-2017-02054
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 12, 2017
    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

    (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.

    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 260, 248, 195, 224 AND 170 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 - 125 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2020 AND OPEN VIAL DATE IS WEEK OF CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): RESULT 1 :260MG/DL DATE: (B)(6) 2017 TIME:2:35PM FASTING. RESULT 2 :248MG/DL DATE:(B)(6) 2017 TIME:2:08PM FASTING, RESULT 3 :195MG/DL DATE:(B)(6) 2017 TIME:1:01PM FASTING, RESULT 4 :224MG/DL DATE:(B)(6) 2017 TIME:1:09PM FASTING, RESULT 5 :170MG/DL DATE:(B)(6) 2017 TIME:5:28PM FASTING, CUSTOMER IS CONCERNED WITH ALL RESULTS. DATE AND TIME ARE NOT SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887854 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5138 00021292008642

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR