BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 23348240 · Received October 21, 2025

    Report

    Report Number
    1000113657-2025-00383
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 21, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO UNDISCLOSED SYMPTOMS RELATED TO DIABETES. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS MOST LIKELY UNDERLYING ROOT CAUSE: MLC-033: AMBIENT TEMPERATURE OUT OF OPERATING RANGE NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 10-OCT-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. CUSTOMER DID NOT DISCLOSE AS TO HOW SHE WAS FEELING AND SHE DID NOT SAY IF WAS STILL HAVING SYMPTOMS OR NOT.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-1). DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-1 ERROR MESSAGE USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/14/2027 AND OPEN VIAL DATE IS 2 DAYS AGO. THE CUSTOMER STATED THAT IS SHE FEELING "WEIRD". SHE COULD NOT DESCRIBE HOW SHE FELT SHE JUST KNOWS SHE NEEDS TO CHECK HER BLOOD GLUCOSE DUE TO HOW SHE FEELS. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976066 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, LEADER TMX 50CTMM MG/DL ZD6150S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other