BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6202160 · Received December 23, 2016

    Report

    Report Number
    1000113657-2016-02081
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 23, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00041220001286
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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: USER HAD AN INACCURATE REFERENCE 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 RESULTS OBTAINED OF 187MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 TO 98MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. 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 FASTING AND PRODUCED TEST RESULTS OF 127 AND 115MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2017 AND OPEN VIAL DATE IS 11/01/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 132MG/DL (B)(6) 2016 12:01 PM FASTING: YES; 131MG/DL (B)(6) 2016 06:45 AM FASTING: YES; 158MG/DL (B)(6) 2016 06:43 AM FASTING: YES; 187MG/DL (B)(6) 2016 06:42 AM FASTING: YES; 129MG/DL (B)(6) 2016 06:28 AM FASTING: YES. CUSTOMER CHANGED EXERCISE ROUTINE; CUSTOMER USED TO WALK TWO MILES AND NOW HE DOES NOT EXERCISE AS MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852471 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1874 00041220001286

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY