BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7396605 · Received April 4, 2018

    Report

    Report Number
    8031673-2018-03375
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    May 18, 2017
    Report Date
    April 4, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ON 19-MAY-2017, AN FSE VISITED THE CUSTOMER SITE AND FOUND THAT THE LEAK SENSOR HAD A SHORT. HE REPLACED THE LEAK SENSOR WITH A NEW ONE AND THEN RAN THE DAILY MAINTENANCE PROCEDURE WHICH PASSED WITH NO LEAK SENSOR ERRORS. THE INSTRUMENT WAS WORKING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A FAULTY LEAK SENSOR.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED OBTAINING ERROR 3022: LEAK SENSOR S702 DETECTED WITH THEIR AIA-360 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN CTNL 2 (TROPONIN) PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF TROPONIN PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240135 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1