BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-600II

    MDR report key: 7315384 · Received March 5, 2018

    Report

    Report Number
    8031673-2018-01649
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    December 18, 2016
    Report Date
    March 5, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE CLEANED THE INCUBATOR OUT AND RAN CUP TRANSFER TESTS AND NOTICED THE PICK UP ARM WAS MOVING A STEP BEFORE PICKING UP CUPS FROM THE INCUBATOR ASSEMBLY. THE FSE ADJUSTED LINE #34 TO MATCH NUMBER #3 ON PARAMETER SETTINGS TO CORRECT ISSUE. AFTER THE SERVICE, THE AIA-600-2 BCR WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. MOST LIKELY CAUSE FOR THIS EVENT WAS WRONG SETTING ON SYSTEM PARAMETERS; THE CUP TRANSFER SETTINGS NEEDED ADJUSTMENT. 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).

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED PICKUP FAILURES, CLUNKING SOUNDS AND BEING UNABLE TO RUN WITH THEIR AIA-600-2 BCR. THE CUSTOMER WAS UNABLE TO RUN BETA-HCG PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA-HCG 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
    155772 AIA-600II AIA-600II KHO TOSOH CORPORATION AIA-600II

    Patients

    Seq Age Sex Outcome Treatment
    1