BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 8652041 · Received May 29, 2019

    Report

    Report Number
    1000113657-2019-00566
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 29, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007638
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT: # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT. MOST LIKELY UNDERLYING ROOT CAUSE MLC-20 USER'S TEST STRIP HAD POOR STORAGE. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED THAT SHE IS GETTING DIFFERENT READINGS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 122, 177, 190, 178, 167, 246 AND 172 MG/DL; RESULTS OF 190 AND 178 MG/DL WERE BACK TO BACK NON-FASTING RESULTS. THE CUSTOMER STATED THAT SHE IS TESTING SAME HAND, DIFFERENT FINGERS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 120 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 180 MG/DL AND 189 MG/DL USING THE METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN (STORAGE INFORMATION WAS NOT OBTAINED UNTIL AFTER THE BLOOD TEST WAS PERFORMED BY CUSTOMER). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2021 AND OPEN VIAL DATE IS 04/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443591 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5310 00021292007638

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR