BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6313765 · Received February 9, 2017

    Report

    Report Number
    1000113657-2017-00243
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    January 15, 2017
    Report Date
    February 9, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00052569138557
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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'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 TESTS RESULTS FROM RESULTS OBTAINED OF 140, 124 AND 116MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 90MG/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 ACCORDING TO SPECIFICATION IN KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/22/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 105MG/DL (B)(6) 2017 07:30 PM FASTING: YES; 140MG/DL (B)(6) 2017 11:28 PM FASTING: YES; 104MG/DL (B)(6) 2017 03:39 PM FASTING: YES; 124MG/DL (B)(6) 2017 09:22 PM FASTING: YES; 116MG/DL (B)(6) 2017 08:34 PM FASTING: YES. THE CUSTOMER IS CALLING IN REGARDS TO GETTING HIGH RESULTS ON THE METER. CUSTOMER SAY HE IS NOT A DIABETIC AND HE JUST WANTS TO KEEP A TRACK ON HIS BLOOD SUGAR. HE HAS NOT HAD ANY CHANGES IN HIS DIET AND HE DOES EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102550 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2134 00052569138557

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY