BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX GO

    MDR report key: 24947825 · Received April 21, 2026

    Report

    Report Number
    1000113657-2026-00174
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 21, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K143548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: SHAKY. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. RETURNED STRIP WERE NOT TESTED AS FAILURE MODE IS A METER EVALUATION ONLY- DISCARDED. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-025: STRIP INSERTED BACKWARDS OR UPSIDE-DOWN. NOTE: 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR DEAD METER. THE CUSTOMER REPORTED FEELING SHAKY; MEDICAL ATTENTION WAS NOT REQUIRED AT THE TIME OF THE CALL. PER THE CUSTOMER HE HAS HAD THE METER SINCE DECEMBER 2025 AND THE BATTERY HAD NOT BEEN CHANGED. DURING THE CALL THE TRUE METRIX GO METER POWERED ON USING THE POWER BUTTON BUT NOT WHEN A TEST STRIP WAS INSERTED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/19/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001545 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, LEADER TMX 50CTMM MG/DL ZD6378S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other