BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 23480660 · Received November 5, 2025

    Report

    Report Number
    1000113657-2025-00405
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 5, 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 AND H1: ADVERSE EVENT AND SERIOUS INJURY BEING SUBMITTED DUE TO CUSTOMER CONTACTING THE PHARMACY DUE TO CONCERN WITH THE HIGH BLOOD GLUCOSE TEST RESULTS OBTAINED. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED 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 31-OCT-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THE REPLACEMENT PRODUCTS DID NOT RESOLVE INITIAL CONCERN AND HE WAS STILL CONCERNED ABOUT HIGH AND ERRATIC BLOOD READINGS. A NEW CASE WAS OPENED TO ADDRESS THE CUSTOMER'S CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162, 163 AND 162 MG/DL. CUSTOMER STATED THE RESULTS WERE HIGHER THAN RESULTS FROM ANOTHER DEVICE. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE AM FASTING: 110-120 MG/DL AND PM FASTING: 130-137 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER CONTACTED THE PHARMACY FOR A REPLACEMENT, AND THEY REFERRED HIM TO THE MANUFACTURER. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/24/2026 AND OPEN VIAL DATE IS 10/14/2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 162 MG/DL DATE:10/16 TIME: 12:24PM FASTING. RESULT 2: 163 MG/DL DATE:10/16 TIME: 7:16AM FASTING. RESULT 3: 162 MG/DL DATE:10/14 TIME: 1:00PM FASTING. RESULT 4: N/A. RESULT 5: N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678186 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 100CT12/CASE MG/DL ZD6099S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown