BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6701331 · Received July 11, 2017

    Report

    Report Number
    1000113657-2017-01347
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 11, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI, 153 AND 537 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 105 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: HI (B)(6) 2017 06:48 AM FASTING:YES; 153MG/DL (B)(6) 2017 06:50 AM FASTING:YES; 136MG/DL (B)(6) 2017 06:48 AM FASTING:YES; 537MG/DL (B)(6) 2017 06:48 AM FASTING:YES; 97MG/DL (B)(6) 2017 06:48 AM FASTING:YES. MEMORY CONCERNS: HI, 153, 136, 537MG/DL. CUSTOMER IS CONCERNED WITH HI READING ON METER. CUSTOMER HAD READING OF 537MG/DL AND HI FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482603 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2383 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR