BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6776758 · Received August 9, 2017

    Report

    Report Number
    1000113657-2017-01533
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 9, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (BATHROOM). TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER MEMORY OF 213, 181, 174, 193 AND 168 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 150 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 213MG/DL N/A 12:00 PM FASTING:YES, THE 181MG/DL N/A 12:00 PM FASTING:YES, THE 174MG/DL N/A 12:00 PM FASTING:YES, THE 193MG/DL N/A 12:00 PM FASTING:YES, THE 168MG/DL N/A 12:00 PM FASTING:YES. MEMORY CONCERNS: 213, 181, 174, 193, 168MG/DL. UNABLE TO VERIFY DATE AND TIME ON METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561379 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1920 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR