BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX

    MDR report key: 23099374 · Received September 19, 2025

    Report

    Report Number
    1000113657-2025-00323
    Event Type
    Death
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 19, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-018: USER HAS HIGH GLUCOSE VALUE. NOTE: CUSTOMER CONTACTED MANUFACTURER ON 28-AUG-2025. CALLER STATED THAT THE CUSTOMER HAD PASSED AWAY ON (B)(6) 2025. AFTER THE INITIAL CALL ON (B)(6) 2025 CUSTOMERS SISTER HAD CALLED THE AMBULANCE. WHEN THEY CAME, CALLER ADVISED THAT THEY TOOK THE CUSTOMER OUT OF THE HOME AND WERE ¿WORKING ON HIM FOR OVER AN HOUR.¿ CALLER ADVISED THAT WHEN THE PARAMEDICS ARRIVED, HIS BREATHING WAS LABORED. CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HE PASSED. CUSTOMER HAD BEEN DIAGNOSED WITH ELEVATED BLOOD GLUCOSE LEVELS; CALLER ADVISED THAT CUSTOMERS BLOOD GLUCOSE WAS OVER 1000 MG/DL. CALLER ADVISED THAT CUSTOMER NEGLECTED HIS DIABETES AND WAS NOT TAKING CARE OF HIMSELF. CALLER ALSO ADVISED THAT THIS WAS THE THIRD TIME IN ONE MONTH IN WHICH THE AMBULANCE WAS CALLED DUE TO THE CUSTOMERS DIABETIC ISSUES.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). SISTER IS CALLING ON BEHALF OF THE CUSTOMER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-5 ERROR MESSAGE USING TRUE METRIX METER. CUSTOMER WAS EXPERIENCING HALLUCINATIONS AND CONFUSION. CALLER ASKED IF SHE SHOULD GIVE CUSTOMER INSULIN AND WAS ADVISED THAT MANUFACTURER IS UNABLE TO ADVISE AS TO MEDICATION. CALLER THEN STATED THAT SHE IS GOING TO CALL THE PARAMEDICS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/29/2027 AND OPEN VIAL DATE IS 08/26/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397155 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 25CT24/CS MG/DL #383237 ZD6135S 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O| H