BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX

    MDR report key: 24576118 · Received March 11, 2026

    Report

    Report Number
    1000113657-2026-00105
    Event Type
    Death
    Date Received
    March 11, 2026
    Report Date
    March 11, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO REPORTED DEATH ON MEDWATCH UNDER MW5183423 (MDR REPORT KEY (B)(4)). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS NOT RETURNED FOR EVALUATION. MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC NOTE: MANUFACTURER MADE THREE ATTEMPTS TO CONTACT CUSTOMER VIA EMAIL REQUESTING ADDITIONAL INFORMATION IN REFERENCE TO MEDWATCH MW5183423 - CUSTOMER DID NOT RESPOND TO THE EMAILS.

    Description of Event or Problem · 0

    MEDWATCH MW5183423 REPORT DATE 10/30/2025 RECEIVED 2/10/2026 DESCRIBING AN EVENT OR PROBLEM AS: "MY FAMILY MEMBER PASSED AWAY WITH USE AND ADJUSTMENTS TO THE TRUE METRIX SELF-MONITORING (B)(6) 2021, (B)(6) HOSPITAL, (B)(6)." NO METER SERIAL NUMBER OR STRIP LOT NUMBER OR CONTACT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595731 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, TRUE METRIX BLANKMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H