BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 24531828 · Received March 6, 2026

    Report

    Report Number
    1000113657-2026-00096
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 6, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES- NAUSEA TEST STRIPS AND METER WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE CUSTOMER WAS NO LONGER EXPERIENCING SYMPTOMS AND TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS WITH USE OF 2 DIFFERENT TIVIDIA METERS. GRAND- DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED WITH CONCERNED WITH THE METER-TO-METER COMPARISON TESTS RESULTS OBTAINED OF SN (B)(6): 370MG/DL AND 530MG/DL WITH SN: (B)(6) (UNDISCLOSED IF FASTING OR NON-FASTING). THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE DID REPORT SYMPTOM OF NAUSEA. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS OR REPORTED SYMPTOM. DURING THE CALL ON (B)(6) 2026, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/21/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589508 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZD6227S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other