BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5668204 · Received May 19, 2016

    Report

    Report Number
    1052693-2016-00966
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 20, 2016
    Report Date
    May 19, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. MOST LIKELY ROOT CAUSE OF PQQ-PD LOT PS2582 WITH LOW GLUCOSE READINGS IS DUE TO RETURNED STRIPS HAD BEEN LEFT OUTSIDE OF THE VIAL FOR A LONG PERIOD TIME WHICH ABSORBED MOISTURE AS A RESULT OF LOW METER GLUCOSE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 113, 101MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-150MG/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 STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/21/2018 AND OPEN VIAL DATE IS 4/13/2016 .THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: UNDISCLOSED. CALLED CUSTOMER ABOUT THE METER, SHE SAID THAT THE METER IS READING LOW, COMPARED TO HER NORMAL; SHE NORMALLY DOES NOT RUN THIS LOW. THE RESULTS ABOVE WERE A FASTING 113MG/DL AND THEN 2 HOURS AFTER EATING A HAMBURGER AND RESULTS WERE 101MG/DL. HER NORMAL WAS BASED ON A DIFFERENT METER SHE HAD BEEN USING BUT ABOUT 1 YEAR AGO THE DR'S BLOOD RESULTS WERE AROUND 140MG/DL FOR A FASTING. NOTHING HAS CHANGED AS FAR AS MEDICATION EXCEPT WITH THIS NEW METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321431 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2582

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR