BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6100468 · Received November 14, 2016

    Report

    Report Number
    1000113657-2016-01860
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 14, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HEMATOCRIT OUTSIDE OF RANGE. MANUFACTURER CONTACTED CUSTOMER WITHIN 24 HOURS URGENT CALL FOR KNOWING CUSTOMER'S CONDITION; AT CALL BACK ON (B)(6) 2016, THE CUSTOMER'S SON STATED THAT THE CUSTOMER'S CONDITION HAD IMPROVED SINCE THE LAST CALL AND THAT WAS CURRENTLY FEELING WELL WITHOUT ANY SYMPTOMS. THE CUSTOMER'S SON STATED THAT LATER ON (B)(6) 2016 (YESTERDAY EVENING AFTER THE ORIGINAL CALL) THE CUSTOMER WENT TO THE HOSPITAL TO HAVE THE BLOOD GLUCOSE TEST AND THE RESULTS IS 280 MG/DL FASTING. THE CUSTOMER'S SON ALSO STATED THAT THE MOTHER WAS NOTIFIED THAT IS SLIGHTLY ANEMIC. THE CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT FROM THE HOSPITAL AND THAT NO NEW MEDICATIONS WERE PRESCRIBED. THE CUSTOMER WAS FOR A SHORT TIME AND LEFT THE HOSPITAL SAME DAY, (B)(6) 2016.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR E-0 ERROR. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE E-0 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP. CUSTOMER INSTRUCTED THE SYSTEM IS DESIGNED TO GIVE ACCURATE GLUCOSE RESULTS FROM BLOOD SAMPLE THAT IS WITHIN HEMATOCRIT RANGE 20%-70%; IF THE HEMATOCRIT RESULTS IS BELOW 20% OR ABOVE 70%,THIS IS A POSSIBLE REASON FOR E-0 ERROR MESSAGE. THE CUSTOMER IS USING ALCOHOL SWABS TO CLEAN THE FINGERTIPS. IT IS NOT RECOMMENDED USE ALCOHOL TO CLEAN FINGERTIPS BUT WASH THEM IN WARM SOAPY WATER. CUSTOMER IS FEELING DIZZY AND WITH STOMACH PAIN. CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION, CUSTOMER DECLINED. A TEST WAS RUN DURING THE PHONE CALL AND PRODUCED E-0 ERROR MESSAGE NEWLY. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. CUSTOMER WAS ENCOURAGE TO SEEK MEDICAL ATTENTION. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(4). MEMORY CONCERNS: UNDISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752071 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1802

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization SECOND THERAPY