BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 22798560 · Received August 13, 2025

    Report

    Report Number
    1000113657-2025-00272
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 13, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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/NURSE DUE TO METER RESULTS. 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-006: PASSED OPEN EXPIRATION DATE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 08-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. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 232, 313, 180 AND 228 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE AM FASTING BELOW 140 MG/DL AND PM FASTING BELOW 200 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER CALLED DOCTOR TODAY ON (B)(6) 2025 DUE TO THE HIGH READINGS AND NURSE TOLD HER TO GET AND APPOINTMENT AND TO CHANGE METER; CUSTOMER GOT AN APPOINTMENT TO CHECK HER BLOOD SUGAR (A1C) ON (B)(6) 2025. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIPS ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 10/31/2025 AND OPEN VIAL DATE IS MORE THAN A YEAR AGO. 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 (DATE/TIME NOT SET): RESULT 1: 232MG/DL DATE: (B)(6) TIME: 2:11PM FASTING FROM TODAY AM RESULT 2: 313MG/DL DATE: (B)(6) TIME: 10:58PM FASTING YESTERDAY PM RESULT 3: 180MG/DL DATE: (B)(6) TIME: 2:02PM FASTING ON (B)(6) 2025 AM RESULT 4: 232MG/DL DATE: ON (B)(6) TIME: 10:32PM FASTING ON (B)(6) 2025 PM RESULT 5: 228MG/DL DATE: ON (B)(6) TIME: 9:54PM FASTING ON (B)(6) 2025 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624784 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZC5651S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other