BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6226705 · Received January 5, 2017

    Report

    Report Number
    1000113657-2017-00017
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 10, 2016
    Report Date
    January 5, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUES. NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2016 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER STATED HIS CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. THE CUSTOMER STATED NO MEDICAL INTERVENTION WAS NEEDED SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 128 MG/DL. DURING THE CALL ON (B)(6) 2016, THE CUSTOMER REPORTED FEELING SLEEPY DUE TO HIS BLOOD RESULT BEING HIGH. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 584 MG/DL USING TRUERESULT METER AND 595 MG/DL USING TRUERESULT METER. CUSTOMER WAS INFORMED THAT TRUERESULT SYSTEM HAS BEEN DISCONTINUED AND TO IMMEDIATELY STOP USE OF TRUERESULT PRODUCTS. REQUESTED CUSTOMER RETURN TRUERESULT PRODUCTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/25/2019 AND OPEN VIAL DATE IS (B)(6) 2016. CUSTOMER'S TEST STRIPS ARE NOT IMPACTED BY RECALL OF BGM PQQ TEST STRIP. WIFE STATED CUSTOMER TAKES INSULIN TO MANAGE HIS DIABETES. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:THE CUSTOMER IS CONCERNED IS WITH THE 2 HI RESULT IN THE METER'S MEMORY I SPOKE TO (B)(6). THE CUSTOMER IS CALLING IN REGARDS TO GETTING HI ON THE METER WHEN HE PERFORMS THE BLOOD TEST. I ADVISE THE HI COULD MEAN THE BLOOD RESULT COULD BE OVER 600MG/DL. THE CUSTOMER SAY THE RESULT COULD BE OVER 600MG/DL BUT DOES NOT NEED MEDICAL ATTENTION. THE CUSTOMER TAKES INSULIN TO MANAGE HIS DIABETES. CUSTOMER SAY THE BLOOD SUGAR HAS NEVER BEEN OVER 300MG/DL. THE RESULT OF THE 242MG/DL WAS NOT FASTING. A BACK TO BACK TEST WAS PERFORMED SINCE THE CUSTOMER WANTED TO MAKE SURE THE RESULT WAS NOT STILL OVER 600MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8649 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2748

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY