BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 24021309 · Received January 9, 2026

    Report

    Report Number
    1000113657-2026-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 17, 2025
    Report Date
    February 18, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 18-FEB-2026: H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE RETURNED - ONLY 1 TEST STRIP IN VIAL, UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(6). METER AND 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-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2026 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 231, 275, 425, 220 AND 173 MG/DL. CUSTOMER CONFIRMED THAT THE BACK-TO-BACK RESULTS WERE TAKEN ONE RIGHT AFTER THE OTHER WITHIN THE 30-MINUTE ALLOTTED TIMEFRAME. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-170 MG/DL. 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/17/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 231 MG/DL DATE: ON (B)(6) 2025 TIME: AM FASTING. RESULT 2: 275 MG/DL DATE: ON (B)(6) 2025 TIME: AM FASTING. RESULT 3: 425 MG/DL DATE: ON (B)(6) 2025 TIME: AM FASTING. RESULT 4: 220 MG/DL DATE: ON (B)(6) 2025 TIME: AM FASTING. RESULT 5: 173 MG/DL DATE: ON (B)(6) 2025 TIME: AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81843 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZD6104S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown