BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 24604403 · Received March 16, 2026

    Report

    Report Number
    1000113657-2026-00113
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 16, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. CUSTOMER RETURNED THE REPLACEMENT METER STRIPS AND CONTROL SOLUTION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 232, 163, 222, 82 AND 131 MG/DL. THE CUSTOMER STATED HER EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 106-116 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. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/21/2026 AND THE OPEN VIAL DATE WAS NOT PROVIDED. 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: RESULT 1: 232 MG/DL, DATE: (B)(6), TIME: 9:14AM FASTING, RESULT 2: 163 MG/DL, DATE: (B)(6), TIME: 9:13AM FASTING , RESULT 3: 222 MG/DL, DATE: (B)(6), TIME: 10:36AM FASTING, RESULT 4: 82 MG/DL ,DATE: (B)(6), TIME: 9:16AM FASTING, RESULT 5: 131 MG/DL, DATE: (B)(6), TIME: 12:18PM NOT SURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663344 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZD6044S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown