BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23271433 · Received October 10, 2025

    Report

    Report Number
    1000113657-2025-00364
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 252, 303, 326, 286, 328 AND 275 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE FASTING AM 99-102 MG/DL AND 2 HRS AFTER A MEAL 160-170 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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2026 AND OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 252 MG/DL DATE: 9/12 TIME: 11:07AM FASTING. RESULT 2: 303 MG/DL DATE:9/12 TIME: 9:00AM FASTING. RESULT 3: 326 MG/DL DATE: 9/12 TIME: 5:56AM FASTING. RESULT 4: 286 MG/DL DATE: 9/12 TIME: 12:46AM FASTING. RESULT 5: 328 MG/DL DATE: 9/11 TIME: 11:30PM FASTING . RESULT 6: 275 MG/DL DATE: 9/11 TIME: 10:06PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487685 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, HMN TMX 100CTMG/DL ZD6117S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown