BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMETRXGO

    MDR report key: 7742199 · Received August 2, 2018

    Report

    Report Number
    1000113657-2018-00817
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    July 11, 2018
    Report Date
    August 2, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007706
    PMA / PMN Number
    K143548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. (B)(4). MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 79 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 131 - 169 MG/DL; EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD OBTAINED THE RESULT OF 79 MG/DL AFTER EATING TWO PIECES OF CAKE AND THAT SHE HAD FELT A LITTLE DIZZY AND BELIEVED IT WAS DUE TO HIGH BLOOD SUGAR. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 157 MG/DL AND 188 MG/DL USING TRUEMETRIX GO METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :91MG/DL DATE: (B)(6) 2018 TIME:11:44AM NON-FASTING; RESULT 2 :79MG/DL DATE: (B)(6) 2018 TIME:11:12AM NON-FASTING; RESULT 3 :91MG/DL DATE: (B)(6) 2018 TIME:11:19AM UNKNOWN; RESULT 4 :110MG/DL DATE: (B)(6) 2018 TIME:5:00PM NON-FASTING; RESULT 5 :111MG/DL DATE: (B)(6) 2018 TIME:10:06AM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585622 TRUMETRXGO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUMETRXGO MV2727 00021292007706

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY