BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7379016 · Received March 28, 2018

    Report

    Report Number
    8031673-2018-03358
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    May 10, 2017
    Report Date
    March 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ON 10-MAY-2017, AN FSE VISITED THE CUSTOMER FACILITIES AND RAN HCL THROUGH SUBSTRATE LINE TO ELIMINATE ANY CONTAMINATION. THEN PERFORMED TIP ALIGNMENTS AND RAN THE TIP MACRO PROCEDURE. ALSO, THE FSE CHECKED THE HYBRID ARM. ON 19-MAY-2017, THE CUSTOMER REPORTED STILL HAVING TIP PICKUP ERRORS. THE FSE RETURNED TO THE CUSTOMER LOCATION, REPEATED THE TIP PICKUP ALIGNMENTS AND RAN TIP PICKUP MACRO. CHECKED THE LEVEL SENSE AND ADJUSTED THE MAIN ARM DUE TO CUSTOMER CONCERN OF SHORT SAMPLE ERRORS. THE INSTRUMENT WAS WORKING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE ANALYZER NEEDING TIP ALIGNMENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED 2207: NO TIP ACQUIRED BY SORTER ALONG WITH ERRORS 4253: HYBRID ARM Z-AXIS HOME OVERRUN INTERMITTENTLY ON THEIR AIA-2000 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN E2, LH-II AND FSH PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF E2, LH-II, AND FSH 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
    221043 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1