BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 22829133 · Received August 18, 2025

    Report

    Report Number
    1000113657-2025-00277
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 18, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-004: IMPROPER TEST METHOD. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-AUG-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGE (E-2). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 211, 246, 231, 160 AND 166 MG/DL THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED DUE TO THE HIGH RESULTS SHE HAD CONTACTED HER DOCTOR ON THE DAY OF THE CALL. CUSTOMER STATED SHE HAD BEEN ADVISED TO CONTINUE TO MONITOR HER BLOOD GLUCOSE. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE (DESK). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2026 AND OPEN VIAL DATE IS 1 MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS UNABLE TO SEE THE DATE/TIME): RESULT 1: 211 MG/DL. DATE: (B)(6) 2025. TIME: 6:58AM FASTING AM. RESULT 2: 246 MG/DL DATE: (B)(6) 2025 TIME: 3:58AM FASTING AM (OVERNIGHT) RESULT 3: 231 MG/DL UNKNOWN TIME: 1:23PM FASTING. RESULT 4: 160 MG/DL UNKNOWN. RESULT 5: 166 MG/DL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590577 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZD6061S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other