BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7329529 · Received March 9, 2018

    Report

    Report Number
    8031673-2018-01547
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 17, 2016
    Report Date
    March 9, 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. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(4). DEVICE BY MANUFACTURER: ON 18-FEB-2016, AN FSE WAS DISPATCHED TO THE CUSTOMER FACILITY TO ADDRESS THE REPORTED EVENT. FSE BEGAN TO TROUBLESHOOT THE ISSUES. FSE REMOVED AND CLEANED WASTE CHUTE FROM BACK OF INSTRUMENT. PERFORMED X AND Y AXIS ADJUSTMENTS FOR SORTER TO CUP TIP LANE AS WELL AS SORTER TO STC LANE. FSE RAN GET CUP MACRO AND GET TIP MACRO THEN BACKED UP MAXIS CONSTANT. THE CUSTOMER RAN QUALITY CONTROLS (QC) IN WHICH ALL RESULTS WERE WITHIN ACCEPTABLE RANGE AND VERIFIED THAT THE ANALYZER WAS FUNCTIONING CORRECTLY. THE AIA-2000ST ANALYZER WAS FUNCTIONING AS INTENDED AND THE ERRORS CLEARED. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS WASTE CHUTE WAS JAMMED.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED CUPS PILING UP FROM BEING DROPPED ERROR 4193 WITH THEIR AIA-2000ST ANALYZER. THE CUSTOMER IS UNABLE TO RUN FSH AND LH II PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING FSH AND LH II PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172022 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1