BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23621003 · Received November 21, 2025

    Report

    Report Number
    1000113657-2025-00428
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 21, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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-REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 10-NOV-2025 TO ENSURE TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INDICATED COMFORTABLE WITH THE GLUCOSE READINGS FROM THE PRODUCT.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 177, 120, 193, 159 AND 96 MG/DL. CUSTOMER ADVISED THAT THE RESULTS FROM THE METER WERE TAKEN 1 RIGHT AFTER THE OTHER. CUSTOMER IS ONLY CONCERNED WITH THE ERRATIC RESULTS AND NOT THE HIGH RESULTS. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE BELOW 90 MG/DL AM FASTING, BELOW 140 MG/DL 1 HR. AFTER MEAL AND BELOW 120 MG/DL 2 HRS. AFTER MEALS. 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 NON-FASTING AND PRODUCED TEST RESULT OF 147 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 04/19/2026 AND OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 177 MG/DL DATE: (B)(6) 2025 TIME: PM 1 HR. AFTER MEAL, RESULT 2: 120 MG/DL DATE: (B)(6) 2025 TIME: PM 1 HR. AFTER MEAL, RESULT 3: 193 MG/DL DATE: (B)(6) 2025 TIME: PM 1 HR. AFTER MEAL, RESULT 4: 159 MG/DL DATE: 10/29/2025 TIME: PM 1 HR. AFTER MEAL, RESULT 5: 96 MG/DL DATE: (B)(6) 2025 TIME: PM 1 HR. AFTER MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559668 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HEB 100CTMG/DL ZC5844S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown