BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 23794743 · Received December 12, 2025

    Report

    Report Number
    1000113657-2025-00464
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 12, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER AND STRIP. 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 04-DEC-2025 TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- THE CUSTOMER IS NOT COMFORTABLE WITH THE REPLACEMENT PRODUCTS. NEW CASE OPENED TO ADDRESS THE CUSTOMER¿S CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS WITH REPLACEMENT METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE AND RESULTS OF CONCERN WERE NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. PER THE CUSTOMER, DUE TO RESULTS HE WENT TO THE DOCTOR A WEEK AGO; HE DID NOT RECALL THE EXACT DAY/DATE HE WENT TO THE DOCTOR, BUT IT WAS AFTER HE RECEIVED AND USED THE REPLACEMENTS. PER THE CUSTOMER HIS DOCTOR DID NOT DO ANYTHING WHEN HE WENT TO DISCUSS THE RESULTS WITH HIM. HE WAS ADVISED HIS A1C RESULT FROM PREVIOUS TEST IS STILL OKAY. HE WAS NOT ELIGIBLE FOR A NEW A1C AT THE TIME OF THE VISIT. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/14/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713707 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 Other