BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7446558 · Received April 20, 2018

    Report

    Report Number
    8031673-2018-04767
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    May 24, 2016
    Report Date
    April 20, 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

    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: A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 31 MAY 2016. THE FSE REPLACED THE AIR PUMP, WASTE PUMP, WASH SYRINGE PUMP AND 3-WAY WASH VALVE. THE DAILY CHECK WAS RUN AND PASSED. A PRECISION RUN ON TROPONIN WAS RUN; ALL VALUES WERE IN RANGE, AND PRECISION WAS GOOD. THE AIA-600II WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO THE 3-WAY WASH VALVE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED AN ONGOING PRECISION ISSUE ON CTNI WITH THEIR AIA-600II 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 CTNI 2 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
    288648 AIA-600II AIA-600II, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1