BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7410461 · Received April 9, 2018

    Report

    Report Number
    8031673-2018-04384
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    October 7, 2016
    Report Date
    April 9, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 7-OCTOBER-2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE SPOKE WITH THE CUSTOMER AND THERE WERE NO ADDITIONAL ISSUES. THE SAMPLE HEAD ASSEMBLY WAS REPLACED DURING A LATER SERVICE CALL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A DEFECTIVE SAMPLE HEAD ASSEMBLY.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED A PRECISION ISSUE WHICH RESULTED IN FALSE RESULTS WITH THE AIA-600II ANALYZER. THE RESULTS ARE DELAYED AS A RESULT OF THE PRECISION ISSUE. THE CUSTOMER IS UNABLE TO RUN BHCG AND CTNL2 PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BHCG AND CTNL2 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
    249069 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1