BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7590805 · Received June 12, 2018

    Report

    Report Number
    8031673-2018-00520
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 12, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE CHANGED THE LEAKING WASH PROBE. THE FSE RAN THE DAILY CHECK AND THE CUSTOMER RAN QUALITY CONTROL (QC). ALL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE AIA-2000 INSTRUMENT WAS OPERATIONAL. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. A COMPLAINT / SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM AWARE DATE OF (B)(6) 2018, WHICH INCLUDED DATA FROM (B)(6) 2017 THROUGH (B)(6) 2018. THE DEVICE WAS REINSTALLED ON (B)(6) 2017. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD, WHICH INCLUDES THIS EVENT. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES ARE AS FOLLOWS: THE (3005) LEAK SENSOR DETECTED LEAKAGE. CAUSE : THE LEAK SENSOR UNDER B/F UNIT DETECTED LEAKAGE. MEASUREMENT IS SUSPENDED. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT WAS THE LEAKING WASH PROBE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A LEAKING WASH PROBE TIP ON THE AIA-2000 INSTRUMENT. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON HCG REPRODUCTIVE HORMONE, BHCG REPRODUCTIVE HORMONE, AND AFP TUMOR MARKER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HCG, BHCG, AND 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
    435609 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000ST

    Patients

    Seq Age Sex Outcome Treatment
    1