BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23784606 · Received December 11, 2025

    Report

    Report Number
    1000113657-2025-00455
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 11, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    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 STRIPS TESTED WITHIN SPECIFICATIONS MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2025 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED IS COMFORTABLE WITH THE GLUCOSE READINGS FROM THE PRODUCT.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 59MG/DL DATE: ON (B)(6) TIME: UNKNOWN FASTING PM AND 79MG/DL DATE: ON (B)(6) TIME: UNKNOWN FASTING AM. CUSTOMER STATED SHE JUST TESTED TODAY; DID NOT WANT TO PROVIDE THE TIME TAKEN. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 80-100 MG/DL FASTING AM AND 120-140 MG/DL FASTING PM. 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. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/14/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS THE DAY BEFORE THE CALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693762 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZD6215S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown