BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7645873 · Received June 28, 2018

    Report

    Report Number
    1000113657-2018-00695
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 28, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00050428264706
    PMA / PMN Number
    K032657
    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: 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. (B)(4). MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 102, 166, 151 AND 298 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 81 - 97 MG/DL. CUSTOMER STATED HE HAS ONLY BEEN USING THE TRUETRACK METER FOR ABOUT A MONTH. 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 135 MG/DL AND 153 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/22/2019 AND OPEN VIAL DATE IS 2 WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:163MG/DL DATE: (B)(6) 2018 TIME:8:37AM FASTING, RESULT 2:201MG/DL DATE: (B)(6) 2018 TIME:10:26AM FASTING, RESULT 3:114MG/DL DATE: (B)(6) 2018 TIME:7:29AM FASTING, RESULT 4:298MG/DL DATE: (B)(6) 2018 TIME:3:57PM FASTING, RESULT 5:151MG/DL DATE: (B)(6) 2018 TIME:3:49PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487380 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RT4971 00050428264706

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR