BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23880571 · Received December 23, 2025

    Report

    Report Number
    1000113657-2025-00476
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 23, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    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). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO CLINIC DUE TO METER ERROR MESSAGES. METER AND 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-003: INCONSISTENT TEST METHOD. 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 ERROR MESSAGES (E-0 AND E-2). PHARMACIST FROM CLINIC IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD GONE TO THE CLINIC DUE TO THE METER ERROR MESSAGES. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/13/2027, AND PER THE CUSTOMER THEY HAD JUST RECEIVED THE METER THE DAY PRIOR TO THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476411 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HNO 50CT24/CS MG/DL ZD6250S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other