BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7221824 · Received January 26, 2018

    Report

    Report Number
    1000113657-2018-00103
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 3, 2018
    Report Date
    February 16, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292001018
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. 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). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER 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 · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 165, 181, 145, 233 AND 165 MG/DL. CUSTOMER IS ALSO CONCERNED WITH ERRATIC BLOOD GLUCOSE TEST RESULTS FROM FASTING BACK TO BACK TESTS DONE DURING THE CALL ON (B)(6) 2018 OF 126 AND 151 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 100 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (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. TEST STRIP (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER 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 TEST RESULTS FROM RESULTS OBTAINED OF 165, 181, 145, 233 AND 165 MG/DL. CUSTOMER IS ALSO CONCERNED WITH ERRATIC BLOOD GLUCOSE TEST RESULTS FROM FASTING BACK TO BACK TESTS DONE DURING THE CALL ON (B)(6) 2018 OF 126 AND 151 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 100 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65341 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5071 00021292001018

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY