BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 22347520 · Received June 27, 2025

    Report

    Report Number
    1000113657-2025-00222
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 27, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. 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-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 19-JUN-2025 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WAS COMPARING THE TRUE METRIX METER TO ANOTHER DEVICE; INTERNAL REPORT REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH, LOW AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 30, 208 AND 194 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS FASTING AM - 102-150 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2026 AND OPEN VIAL DATE IS 1-2 WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 71 MG/DL, DATE: (B)(6), TIME: 2:00PM FASTING, RESULT 2 134 MG/DL , DATE: (B)(6), TIME: 9:21AM FASTING, RESULT 3: 116 MG/DL , DATE: (B)(6), TIME: 10:07PM FASTING/ BEDTIME, RESULT 4: 208 MG/DL, DATE: (B)(6), TIME: 4:41PM FASTING/BEFORE LUNCH, RESULT 5: 168 MG/DL, DATE: (B)(6), TIME: 12:44PM FASTING BEFORE LUNCH, RESULT 6: 121 MG/DL, DATE: (B)(6), TIME: 10:07AM FASTING , RESULT 7: 118 MG/DL , DATE: (B)(6), TIME: 8:25PM FASTING/BEDTIME , RESULT 8: 30 MG/DL, DATE: (B)(6), TIME: 4:34PM UNKNOWN, RESULT 9: 122 MG/DL , DATE:(B)(6), TIME: 2:14PM FASTING/BEFORE LUNCH , RESULT 10 :194 MG/DL, DATE: (B)(6), TIME: 11:25AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973184 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZD6022S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown