BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 24094041 · Received January 16, 2026

    Report

    Report Number
    1000113657-2026-00021
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 11, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED - PRODUCT EVALUATION IN PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT 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 SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 11-FEB-2026: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(6): DESCRIPTION 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 209, 204, 210, 143 AND 228 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 90MG/DL FASTING AM, AND 140MG/DL FASTING PM 2 HOURS POST MEAL. 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. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/13/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 4 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 209MG/DL, DATE: (B)(6) 2025, TIME: 12:54PM FASTING PM, RESULT 2: 204MG/DL , DATE: (B)(6) 2025 , TIME: 12:52PM FASTING PM , RESULT 3: 210MG/DL, DATE: (B)(6) 2025 , TIME: 11:49PM FASTING PM , RESULT 4: 143MG/DL , DATE: (B)(6) 2025, TIME: 12:59AM FASTING AM , RESULT 5: 228MG/DL , DATE: (B)(6) 2025 , TIME: 11:24PM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155054 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 50CT24/CASE MG/DL ZD6249S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown