BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 6880769 · Received September 20, 2017

    Report

    Report Number
    1000113657-2017-01731
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 20, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292008642
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN).

    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 303, 339 AND 274 MG/DL. CUSTOMER IS ALSO CONCERNED WITH ERRATIC FASTING RESULTS OF 172 AND 274 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 - 185 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 NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN ON TOP OF THE REFRIGERATOR. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 303MG/DL (B)(6) 2017 08:46 AM FASTING:YES, THE 339MG/DL (B)(6) 2017 08:27 AM FASTING:YES, THE 274MG/DL (B)(6) 2017 08:16 AM FASTING:YES, THE 172MG/DL (B)(6) 2017 08:15 AM FASTING:YES, THE 178MG/DL (B)(6) 2017 08:10 AM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH 303, 339, 274MG/DL HIGH FASTING RESULTS AND IS ALSO CONCERNED WITH ERRATIC FASTING RESULTS 172 AND 274MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659550 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RS4822 00021292008642

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR