BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 5898012 · Received August 23, 2016

    Report

    Report Number
    1000113657-2016-01396
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 23, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD A POOR STORAGE(KITCHEN).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 139, 152, 163, 159MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 125MG/DL FASTING AND WITHIN TWO HOURS AFTER EATING BETWEEN 160-180 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER ON-FASTING AND PRODUCED TEST RESULTS OF 141 AND 136 MG/DL USING TRUE METRIX METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES PRODUCT IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 139MG/DL (B)(6) 2016 07:35 AM FASTING: YES, 152MG/DL (B)(6) 2016 07:33 AM FASTING: YES, 163MG/DL (B)(6) 2016 07:32 AM FASTING: YES, 159MG/DL (B)(6) 2016 07:31 AM FASTING: YES, 121MG/DL (B)(6) 2016 07:28 AM FASTING: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548388 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1575

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR