BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23751165 · Received December 8, 2025

    Report

    Report Number
    1000113657-2025-00452
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 8, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 04-DEC-2025 TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- THE CUSTOMER IS COMFORTABLE WITH THE REPLACEMENT PRODUCTS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 192, 380, 280, 233 AND 242 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEAT RESULT RANGES ARE 80 MG/DL FASTING AM AND 150MG/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 BEDROOM. CUSTOMER NO LONGER HAD THE TEST STRIP VIAL OR LOT NUMBER AVAILABLE. PER THE CUSTOMER THE OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 192MG/DL, DATE:11/11, TIME: 9:30P, FASTING PM. RESULT 2: 380MG/DL, DATE:11/10, TIME: 2:30P, FASTING PM. RESULT 3: 280MG/DL DATE:11/09, TIME: 8:22P, FASTING PM. RESULT 4: 233MG/DL DATE:11/08, TIME:10A FASTING AM. RESULT 5: 242MG/DL, DATE: 11/07, TIME: 9:00A FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858558 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown