BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000 LA

    MDR report key: 16792770 · Received April 23, 2023

    Report

    Report Number
    3004529019-2023-00310
    Event Type
    Malfunction
    Date Received
    April 23, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 23, 2023
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284623
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) CONDUCTED A SITE VISIT AND WAS ABLE TO CONFIRM THE COMPLAINT BY ATTEMPTING TO RUN A TEST AND CHECKING ERROR LOGS. FSE OBSERVED LIQUID LEVEL AD VALUE AND FOUND THAT THEY HAD SHIFTED AND SHIFTED WHEN THE MAIN ARM MOVED. UPON FURTHER INSPECTION, FSE IDENTIFIED THAT A SCREW WAS LOOSE SECURING THE LIQUID SURFACE DETECTION BOARD (EKI BOARD). FSE RESOLVED THE COMPLAINT BY ADJUSTING THE EKI BOARD AND SECURED IN ITS HOUSING. AS A PRECAUTION, FSE ADJUSTED PARAMETERS AND ALIGNMENTS IN THE EVENT THE SHIFT IS DUE TO THE LOOSE BOARD. THE FSE VALIDATED THE ANALYZER BY SUCCESSFULLY PERFORMING QUALITY CONTROL (QC) WITHIN AN ACCEPTABLE RANGE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH THE AWARE DATE OF THE EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO OTHER COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATORS MANUAL UNDER APPENDIX 4: ERROR MESSAGES STATE THE FOLLOWING: [2066] FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM CAUSE : THE LIQUID LEVEL WAS DETECTED BEFORE REACHING THE SURFACE OF THE SPECIMEN. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE EKI BOARD NOT BEING SECURED IN ITS HOUSING.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED 2066 (2000 ONLY) FALSE DETECTION OF SPECIMEN LEVEL BY MAIN ARM ERROR ON THE AIA-2000 ANALYZER. TECHNICAL SUPPORT SPECIALIST ADVISED CUSTOMER TO CLEAN PROBE WELLS AS THE CUSTOMER OBSERVED LIQUID BUILD UP. THE ISSUE PERSISTED AND THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ISSUE WHICH CAUSED DELAY IN REPORTING ALPHA-FETOPROTEIN (AFP) PATIENT SAMPLES. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446680 AIA-2000 LA FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 LA N/A 04560189284623

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown