BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 14312420 · Received May 6, 2022

    Report

    Report Number
    3004529019-2022-00089
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 25, 2022
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    KHO
    UDI-DI
    04560189284616
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEERING (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS REPORTED EVENT. FSE CONFIRMED THE COMPLAINT BY REVIEWING THE ERROR LOGS AND REPRODUCED ERROR BY TURNING ON THE ANALYZER. WHILE TROUBLESHOOTING, FSE FOUND THE CABLING GOING TO THE EKI BOARD WAS SHORTED TO THE GROUND BY THE EKI BOARD COVER CAUSING THE ANLG BOARD TO LOOSE THE 15 VOLTS NEEDED FOR THESE ASSEMBLIES. FSE RESOLVED COMPLAINT BY REPLACING THE SAMPLER Z-AXIS CABLE THAT GOES TO THE EKI BOARD. FSE ALSO ADJUSTED THE EKI BOARD FOR PROPER A/D LEVEL AND ADJUSTED THE CLOT DETECTION, VERIFIED ALL POWER SUPPLY CONNECTIONS AND VOLTAGES AND ALL CABLE CONNECTIONS TO THE ANLG, SENS, AND BFIF BOARDS, ALSO VERIFIED ALL TEMPERATURES AND VERIFIED PROPER WASH SENSITIVITY. THE FSE SUCCESSFULLY PERFORMED DAILY MAINTENANCE AND QUALITY CONTROL RUNS WITHOUT ERROR AND WITHIN ACCEPTABLE RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 ANALYZER IS FUNCTIONING AS EXPECTED. THE AIA-2000, SERIAL NUMBER (B)(4) WAS INSTALLED ON (B)(6) 2022. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM INSTALLATION DATE THROUGH AWARE DATE. THERE WERE TWO (2) SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES STATES THE FOLLOWING: 3054 DETECTOR TEMPERATURE CONTROL ABNORMAL. CAUSE : DISCONNECTION OF THE DETECTOR TEMPERATURE SENSOR WAS DETECTED. THE CURRENT MEASUREMENT WILL BE FLAGGED (IO FLAG) AND NEW MEASUREMENTS WILL BE SUSPENDED. SOLUTION : RESET THE MAIN POWER. CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 2240 B/F PROBE 2 PURGE FAILURE. CAUSE : THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION : AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO FAILURE OF THE SAMPLER Z-AXIS CABLE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER 10661001, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCE, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED GETTING ERROR MESSAGES "3054 DETECTOR TEMPERATURE CONTROL ABNORMAL AND "2240 BF PROBE 2 PURGE FAILURE" ON THE AIA-2000 ANALYZER. 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 ALPHA-FETOPROTEIN (AFP). 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
    1281354 AIA-2000 FLUOROMETER, FOR CLINICAL USE KHO TOSOH HI-TEC, INC. AIA-2000 ST N/A 04560189284616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown