BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 23967314 · Received January 5, 2026

    Report

    Report Number
    1000113657-2026-00001
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 5, 2026
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: THIRST AND FREQUENT URINATION. 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-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE: MANUFACTURER UNABLE TO PERFORM FOLLOW-UP CALL TO CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - CUSTOMER DOES NOT HAVE A TELEPHONE AND HAD USED A FRIEND'S PHONE AT THE TIME OF THE INITIAL CALL AND DECLINED TO PROVIDE THE TELEPHONE NUMBER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (UNKNOWN). CUSTOMER STATED HE DID NOT RECALL THE SPECIFIC ERROR MESSAGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF THIRST AND FREQUENT URINATION. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/21/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29061 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX FNT 50CT MEDI-MEDI MG/DL ZD6225S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other