BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5534399 · Received March 30, 2016

    Report

    Report Number
    1052693-2016-00627
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 6, 2016
    Report Date
    March 30, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    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. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUE OR/AND SAMPLE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS (LESS THAN 20MG/DL) AND E5 ERROR MESSAGES. (B)(6) IS CALLING ON BEHALF OF THE CUSTOMER ((B)(6)). CUSTOMER STATES THAT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 130MG/DL-150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 9/30/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN STORED IN THE KITCHEN AND WERE FIRST OPENED IN JANUARY 2016. (B)(6) STATES THE ERROR MESSAGE APPEARS WHEN THE BLOOD SAMPLE APPLIED.-THE CUSTOMER HAS NOT SYMPTOMS SUCH AS FATIGUE, EXCESS URINATION, THIRST, OR BLURRY VISION. NO ADVERSE EVENT REPORTED. REVIEWED METER MEMORY 228MG/DL (B)(6) 2016 05:33:00 AM FASTING:YES; LO (B)(6) 2016 05:30:00 AM FASTING:YES; 32MG/DL (B)(6) 2016 05:27:00 AM FASTING:YES; 170MG/DL (B)(6) 2016 05:33:00 AM FASTING:YES; 159MG/DL (B)(6) 2016 05:40:00 AM FASTING:YES. THE CUSTOMER IS CONCERNED WITH THE LO RESULT IN THE METER'S MEMORY. CUSTOMER STATES IT MAY HAVE NOT BEEN LOW SINCE DID NOT HAVE ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192397 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2530

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY