BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15808064 · Received November 16, 2022

    Report

    Report Number
    1000113657-2022-00599
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 16, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC: 062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALLS ON(B)(6)2022 AND (B)(6)2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN. ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INITIALLY STATED ON (B)(6)2022 CALL THAT THE REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. ON (B)(6) 2022, CUSTOMER STATED THAT THE REPLACEMENT PRODUCTS DID NOT RESOLVE THE INITIAL CONCERN (INTERNAL REPORT REFERENCE (B)(4)).

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED HE IS USING TWO DIFFERENT VIALS OF TEST STRIPS WITH THE TRUE METRIX METER (INTERNAL REPORT REFERENCE 123525-1). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 291, 181, 123 AND 159 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 119-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER NO LONGER HAD ANY TEST STRIPS FROM THIS VIAL AND WAS NOT ABLE TO PROVIDE LOT INFORMATION. CUSTOMER STATED THE TEST STRIPS HAD BEEN OPENED ONE MONTH PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; CUSTOMER STATED ALL WERE AM RESULTS): RESULT 1: 179 MG/DL. DATE: 02/14. TIME: 10:07 PM. FASTING. RESULT 2: 291 MG/DL. DATE: 02/14. TIME: 10:06 PM. FASTING. RESULT 3: 181 MG/DL. DATE: 02/13. TIME: 9:03 PM. FASTING. RESULT 4: 123 MG/DL. DATE: 02/12. TIME: 10:07 PM. FASTING. RESULT 5: 159 MG/DL. DATE: 02/11. TIME: 10:12 PM. FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832767 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown