BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-1800

    MDR report key: 7344115 · Received March 15, 2018

    Report

    Report Number
    8031673-2018-02222
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    June 2, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TOSOH FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE TO EVALUATE THE PROBLEM. THE FSE CHECKED THE SUBSTRATE FLOW TO THE INCUBATOR AND FOUND THE FLOW TO BE GOOD. NEXT THE FSE CHECKED FOR AIR IN THE SUBSTRATE SYSTEM AND FOUND NO AIR. THE FSE RESEATED THE CABLE FROM THE DETECTOR TO THE MAIN BOARD. FOLLOWING, THE CUSTOMER RAN CONTROLS AND RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE AIA-1800 ANALYZER WAS VERIFIED FOR PROPER OPERATION AND READY FOR USE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS RELATED TO A FAULT OF THE DETECTOR. THE AIA-1800 SERVICE, OPERATOR'S, AND TRAINING MANUALS WERE REVIEWED AND FOUND TO CLEARLY ADDRESS CALIBRATION, OPERATION, MAINTENANCE OF THE SUBSTRATE SYSTEM, DL FLAG, AND TROUBLESHOOTING PERTAINING TO THE AIA-1800 SYSTEM DL -INDICATES MALFUNCTION IN DETECTOR UNIT OR SUBSTRATE DISPENSE FAILURE. CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVE. PRINT, DISPLAY (RATE VALUE) :OUTPUTS OBTAINED VALUE PRINT, DISPLAY (CONCENTRATION VALUE): BLANK. RS232C OUTPUT (CONCENTRATION VALUE) : FOLLOW THE "FLAG 1" SETTING OF THE UTILITY-HOST SCREEN. RS232C OUTPUT (FLAG): A. 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 (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER CALLED TOSOH TECHNICAL SUPPORT TO REPORT THAT THEY ARE STILL RECEIVING THE DL FLAG DURING USE OF THE AIA-1800 ANALYZER. THE CUSTOMER REPORTED THAT A FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO FIX THE PROBLEM BUT IT IS NOT FIXED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BHCG AND AFP 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
    187040 TOSOH AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-1800 AIA-1800 KHO TOSOH CORPORATION AIA-1800 ST

    Patients

    Seq Age Sex Outcome Treatment
    1