BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 24318756 · Received February 11, 2026

    Report

    Report Number
    3004529019-2026-00014
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 11, 2026
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THE FSE CONFIRMED THE ERROR BY OBSERVING A BLUE COMPUTER SCREEN AND THE COMPUTER NOT BOOTING UP. THE FSE ATTEMPTED SEVERAL TIMES TO BOOT UP THE COMPUTER WITHOUT SUCCESS. THE FSE REPLACED THE ALL-IN-ONE COMPUTER WITH HP MINI COMPUTER. THE CUSTOMER VERIFIED THE RESOLUTION BY RUNNING SEVERAL CALIBRATIONS AND QUALITY CONTROL (QC) WITHOUT ISSUES AND WITHIN SPECIFICATIONS. NO FURTHER ACTION REQUIRED BY THE FSE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW THROUGH THE AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR FAILURE MODE "COMPUTER STARTUP FAILURE" ON THE AIA-2000ST ANALYZER. THERE WERE THREE SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD, INCLUDING THIS CASE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS COMPONENT FAILURE OF THE COMPUTER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED "STARTUP REPAIR AND BACKUP FAILED ON THE COMPUTER¿ UNABLE TO LAUNCH SOFTWARE ISSUES ON THE AIA-2000 ANALYZER. THE CUSTOMER REBOOTED THE COMPUTER, BUT THE ISSUE PERSISTS. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO SHUTDOWN THE COMPUTER AND ANALYZER. UPON STARTING UP, THE COMPUTER DISPLAYED, CHOOSE KEYBOARD LAYOUT, AND IS SLOW. THE SOFTWARE WILL STILL NOT LAUNCH. THE ANALYZER IS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT WHICH RESULTED IN A DELAYED REPORTING OF PATIENT SAMPLES FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). THERE IS 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
    376467 AIA-2000 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000ST 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown