BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18257039 · Received December 4, 2023

    Report

    Report Number
    1000113657-2023-00583
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 4, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    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). METER WAS RETURNED - REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. TEST STRIPS WERE NOT RETURNED - CUSTOMER HAD RETURNED THE INCORRECT TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN- UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 155 AND 197 MG/DL. CUSTOMER WAS ALSO PERFORMING METER TO METER COMPARISON; RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 225-250 MG/DL AND EXPECTED BLOOD GLUCOSE TEST RESULT 2 HOURS POST MEAL IS 350 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. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER 2 HOURS POST MEAL AND PRODUCED TEST RESULT OF 293 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/23/2025 AND OPEN VIAL DATE IS 1 WEEK PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 155 MG/DL DATE: (B)(6) 2023 TIME: 5:57 PM 2 HRS. AFTER MEAL RESULT 2: 234 MG/DL DATE: (B)(6) 2023 TIME: 6:27 AM FASTING RESULT 3: 232 MG/DL DATE: (B)(6) 2023 TIME: 1:47 AM FASTING RESULT 4: 208 MG/DL DATE: (B)(6) 2023 TIME: 1:44 AM FASTING RESULT 5: 197 MG/DL DATE: (B)(6) 2023 TIME: 2:48 AM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429427 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZB5451S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown