BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 8531540 · Received April 19, 2019

    Report

    Report Number
    1000113657-2019-00357
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 19, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INDICATED THAT HE IS NOW USING A DIFFERENT METER.

    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 260, 232, 207 AND 213 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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. DURING THE CALL A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 212 MG/DL AND 233 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2021 AND TEST STRIPS WERE OPENED TWO MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326935 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5320

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR