BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7355156 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-02958
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    January 27, 2017
    Report Date
    March 20, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 27 JANUARY 2017. THE FSE REPLACED THE WASH SUPPLY VALVES. THE ENGINEER REPORTED AFTER RUNNING QUALITY CONTROL THE RECOVERY PRECISION WAS GOOD.THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS THE WASH SUPPLY VALVES.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED QUALITY CONTROL RESULTS FOR FSH DRIFTING LOW WITH THEIR AIA-900 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING FSH PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197764 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1