BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6129242 · Received November 28, 2016

    Report

    Report Number
    1000113657-2016-01914
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 28, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER; RETURNED TEST STRIPS ARE USED; UNABLE TO EVALUATE. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 216, 221 AND 201 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 118 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 FASTING AND PRODUCED TEST RESULTS OF 194 MG/DL AND 199 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 216MG/DL, (B)(6) 2016 03:13 PM, FASTING:YES. A 175MG/DL, (B)(6) 2016 08:55 AM, FASTING:YES. A 192MG/DL, (B)(6) 2016 08:39 AM, FASTING:YES. A 221MG/DL, (B)(6) 2016 03:17 PM, FASTING:YES. A 201MG/DL, (B)(6) 2016 03:18 PM, FASTING:YES. MEMORY CONCERNS: ALL HIGH RESULTS. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN DIET, EXERCISE, OR MEDICATIONS CUSTOMER STATES DOES NOT HAVE ANY GLUCOSE CONTROL SOLUTION AVAILABLE AT THIS TIME IN ORDER TO RUN A CONTROL SOLUTION TEST ON SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781396 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1960

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY