BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6784442 · Received August 10, 2017

    Report

    Report Number
    1000113657-2017-01536
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 10, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006068
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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: MLC-20-USER'S TEST STRIP HAD POOR STORAGE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 193 AND 166 MG/DL AND OF HIGH RESULT OF 199 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 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; CUSTOMER IS STORING STRIPS IN A METAL CAN IN THE CLOSET WITH NO CENTRAL AIR CONDITIONING IN THE HOME. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/16/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 145MG/DL , (B)(6) 2017, 04:48 PM, FASTING: YES; 193MG/DL, (B)(6) 2017, 04:46 PM, FASTING: YES; 99MG/DL, (B)(6) 2017, 04:45 PM, FASTING: YES; 166MG/DL, (B)(6) 2017, 04:43 PM, FASTING: YES; 199MG/DL, (B)(6) 2017, 12:00AM, FASTING: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565479 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2392 00021292006068

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR