BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 21567437 · Received March 10, 2025

    Report

    Report Number
    1000113657-2025-00075
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 10, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). 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-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 ERRATIC, HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED YESTERDAY 02/12/2025: 98 MG/DL 2AM, 100 MG/DL 7AM, BETWEEN 7AM AND 10AM STILL FASTING: 125 MG/DL, 145 MG/DL, 138 MG/DL, 112 MG/DL, 103 MG/DL, AFTERNOON 78M MG/DL FASTING. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS AM FASTING 79-90 MG/DL AND 170 MG/DL PM FASTING. 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2025 AND 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 NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031574 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZB5379S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown