BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8211098 · Received January 2, 2019

    Report

    Report Number
    8031673-2018-05363
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 2, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED THAT THE 2043 ERROR MESSAGE BUT RUNNING A DAILY CHECK. FSE PERFORMED TROUBLESHOOTING AND FOUND A BROKEN WIRE ON THE CABLE 3 HARNESS ASSEMBLY. FSE REPLACED THE CABLE-3 BF PROBE PULSE MOTOR, WHICH RESOLVED THE ISSUE. FSE THEN RAN QUALITY CONTROLS WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 05-NOV-2017 THROUGH 05-DEC-2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4 - ERROR MESSAGES STATES THE FOLLOWING: [2043] B/F WASH CONTROL START DELAY CAUSE : B/F WASH CONTROL OPERATION FAILED TO COMPLETE WITHIN THE DESIGNATED 18 SEC CYCLE. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. IT IS NECESSARY TO CHECK POSITION ADJUSTMENT OF ACTUATOR OF B/F WASH. [4461] B/F PROBE 3 HOME DETECTION FAILURE CAUSE : THE HOME SENSOR FAILED TO ACTIVATE AFTER B/F PROBE 3 MOVED TOWARD THE HOME POSITION. THE MEASURING OPERATION IS SUSPENDED. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED ERROR MESSAGES WAS DUE TO A BROKEN WIRE ON B/F UNIT CABLE-3 ASSEMBLY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING ERROR MESSAGES 2043 B/F WASH CONTROL START DELAY AND 4461 B/F PROBE 3 HOME DETECTION FAILURE WITH THE AIA-2000 INSTRUMENT. THE CUSTOMER REPLACED THE TIPS ON THE B/F PROBES AND CLEANED THEM. THE CUSTOMER THEN PERFORMED AN ALL SET HOME, BUT THE ERRORS PERSISTED. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF ALPHA FETOPROTEIN (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
    3394 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1