BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23268815 · Received October 10, 2025

    Report

    Report Number
    1000113657-2025-00363
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 10, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. 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-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE 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 HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS COMPARING 2 TRUE METRIX METERS USING THE SAME BOTTLE OF TEST STRIPS. CUSTOMER STATED BOTH METERS ARE READING HIGH AND SHE WAS ALSO CONCERNED ABOUT THE DIFFERENCE BETWEEN METERS; ADDITIONAL REPORT REFERENCE NUMBER 181998-1. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 360, 203, 252 AND 127 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 100-120 MG/DL AM FASTING AND 160-180 MG/DL PM FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2026 AND OPEN VIAL DATE IS 1 MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET, ALL TESTS WERE PERFORMED IN THE AM): RESULT 1: 360 MG/DL DATE: 3/24 TIME: 12:22PM FASTING (B)(6) 2025. RESULT 2: 203 MG/DL DATE: 3/23 TIME: 11:57PM FASTING (B)(6) 2025. RESULT 3: 252 MG/DL DATE: 3/22 TIME: 10:31 PM FASTING (B)(6) 2025. RESULT 4: 127 MG/DL DATE: 3/20 TIME: 9:35PM FASTING (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279592 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX PBX 100CT12/CASE MG/DL ZD6089S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown