BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 24092928 · Received January 16, 2026

    Report

    Report Number
    1000113657-2026-00019
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 16, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: TIRED. 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-025: STRIP INSERTED BACKWARDS OR UPSIDE-DOWN. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-JAN-2026 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN -ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THEY ARE COMFORTABLE WITH THE GLUCOSE READINGS FROM THE NEW REPLACEMENT PRODUCTS. UNABLE TO CONFIRM WHETHER OR NOT THE CUSTOMER WAS STILL EXPERIENCING SYMPTOMS.

    Description of Event or Problem · 0

    CONSUMER INITIALLY CALLED TO SET TIME AND DATE ON REPLACEMENT METER. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. DURING THE CALL THE TRUE METRIX METER POWERED ON USING THE POWER BUTTON BUT NOT WHEN A TEST STRIP WAS INSERTED. CUSTOMER REPORTED FEELING TIRED AND DRAINED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/14/2027; CUSTOMER HAD JUST RECEIVED THE REPLACEMENT PRODUCTS ON THE DAY OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152708 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, TRUE METRIX BLANKMG/DL ZD6222S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other