BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 21087460 · Received January 6, 2025

    Report

    Report Number
    3004529019-2025-00677
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 7, 2025
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189283992
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CONFIRMED THE REPORTED ISSUE WHEN VERIFYING THE ALIGNMENTS. THE FSE VERIFIED THE ALIGNMENT OF THE SPECIMEN NOZZLE AT THE D. LANE AND FOUND AN ALIGNMENT ISSUE, BUT WAS UNABLE TO DETERMINE WHAT CAUSED THE MISALIGNMENT. THE FSE REALIGNED THE SPECIMEN NOZZLE Y AXIS TO THE LANE AND VERIFIED THE ANALYZER BY RUNNING QUALITY CONTROL (QC) AND DAILY CHECK WITH RESULTS WITHIN ACCEPTABLE RANGE. THE ANALYZER IS OPERATING AS EXPECTED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6). THERE WERE NO OTHER SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD THE AIA-900 OPERATORS MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [2160] TRANSFER NOT DETECTED CUP CAUSE: THE CUP SENSOR S063 FAILED TO DETECT THE CUP BEFORE IT WAS GRASPED. ACTION: PLEASE CONTACT THE TOSOH LOCAL REPRESENTATIVES. CHECK S063, THE CUP PICKUP POSITION, AND THE CUP PICKUP OPERATION. THE AIA-900 OPERATORS MANUAL UNDER SECTION 12: FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [4111] SAMPLE-Y HOME NOT DETECTED CAUSE: THE HOME SENSOR S050 FAILED TO BE ACTIVATED AFTER THE SPECIMEN DISPENSING ARM MOVED TOWARD THE HOME POSITION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S050 AND PM050 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE WAS DUE TO A MISALIGNMENT OF THE SAMPLE NOZZLE Y AXIS TO THE LANE, CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED 2160 (900 ONLY) C TRANSFER NOT DETECTED CUP ERROR AND 4111 (900 ONLY) SAMPLE-Y HOME NOT DETECTED ON THE AIA-900 ANALYZER. THE CUSTOMER RESTARTED THE ANALYZER AND CONFIRMED THE WASTE WAS EMPTY, BUT ISSUE REMAINS. 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
    382381 AIA-900 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-900 N/A 04560189283992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown