BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7146583 · Received December 26, 2017

    Report

    Report Number
    1000113657-2017-02115
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 26, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4)-USER'S TEST STRIP HAD POOR STORAGE.(KITCHEN). (B)(4). CUSTOMER REPORTED SYMPTOM OF STRESS. TEST STRIP UDI# (B)(4). NOTE: AT CALL BACK ON (B)(6) 2017, THE CUSTOMER'S CONDITION REMAINED THE SAME SINCE THE TIME OF INITIAL CONTACT. THE CUSTOMER REPORTED SYMPTOMS OF BLURRED VISION, STRESS AND NEUROPATHY IN FEET, AN INTENSE FEELING OF BURNING SENSATION. THE CUSTOMER DID NOT RECEIVE ANY MEDICAL INTERVENTION SINCE THE LAST CALL. THERE WERE NO ADDITIONAL BLOOD TESTS PERFORMED WITH THE TRUEMETRIX METER. UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE AT CALL BACKS ON 12/11/2017 AND 12/12/2017. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 130, 142, 144, 137 AND 123 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 100 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF BLURRED VISION, STRESS, NEUROPATHY IN FEET, AN INTENSE FEELING OF BURNING SENSATION. CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 142 MG/DL AND 130 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; RESULTS FROM LOG BOOK): RESULT 1 :130MG/DL DATE: (B)(6) 2017 TIME:11:55AM FASTING. RESULT 2 :142MG/DL DATE: (B)(6) 2017 TIME:11:50AM FASTING. RESULT 3 :144MG/DL DATE: (B)(6) 2017 TIME:11:30AM FASTING. RESULT 4 :137MG/DL DATE: (B)(6) 2017 TIME:11:27AM FASTING RESULT 5 :123MG/DL DATE: (B)(6) 2017 TIME:11:25AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925858 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2616 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR