BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6734609 · Received July 21, 2017

    Report

    Report Number
    1000113657-2017-01466
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 21, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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: (B)(4) USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 140 MG/DL. CUSTOMER STATED HE ONLY TESTS THREE TIMES A WEEK. CUSTOMER STATED HE HAD NOT BEEN USING THE METER FOR A WHILE. 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 STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/18/2018. CUSTOMER DID NOT REMEMBER THE OPEN VIAL DATE. TEST STRIPS ARE NOT IMPACTED BY RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 40MG/DL (B)(6)2017 03:24 PM FASTING: YES. A LO (B)(6)2017 02:17 PM FASTING: YES. A 42MG/DL (B)(6)2017 04:28 PM FASTING: YES. A 30MG/DL (B)(6)2017 04:28 PM FASTING: YES. A LO (B)(6)2017 04:28 PM FASTING :YES. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. CUSTOMER STATES THAT THE METER IS GIVING RESULTS LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513703 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2465

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR