BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6685902 · Received July 5, 2017

    Report

    Report Number
    1000113657-2017-01182
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 5, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007065
    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 OF MALFUNCTION: MLC 20 -USER'S TEST STRIP HAD POOR STORAGE. (KITCHEN). (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 859 TO 95MG/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. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 164MG/DL (B)(6) 2017 01:28 PM FASTING: YES; 139MG/DL (B)(6) 2017 12:00 PM FASTING: YES; 125MG/DL (B)(6) 2017 12:00 PM FASTING: YES; 110MG/DL (B)(6) 2017 10:00 AM FASTING: YES; 113MG/DL (B)(6) 2017 12:00 AM FASTING: YES. CUSTOMER IS CONCERNED WITH HIGH READINGS. RESULTS OF CONCERN IS 110, 113, 125, 139, 164MG/DL FASTING. EXPECTED FASTING RAND IS 89-95MG/DL. CUSTOMER DENIES HAVING SIGNS AND SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER DENIES NEED FOR MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468798 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1906 00021292007065

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY