BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7364653 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03341
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    May 30, 2017
    Report Date
    March 22, 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 30-MAY-2017, AN FSE VISITED THE CUSTOMER SITE AND FOUND THAT EKI BOARD WAS NOT ADJUSTING UP TO THE CORRECT VALUE. HE REPLACED THE EKI BOARD AND ADJUSTED IT. ALSO, HE RECALCULATED K1 FOR BOTH MAIN AND HYBRID ARMS. THE HYBRID ARM K1 REQUIRED ADJUSTMENT WHILE THE MAIN ARM K1 DID NOT. ON 31-MAY-2017 THE FSE RETURNED TO THE FACILITY, RAN CONTROLS ON ALL ASSAYS WITH NO ERRORS ON PRETREATMENT OR MAIN ARM, AND RECHECKED ALL HYBRID ARM ALIGNMENTS. THE INSTRUMENT WAS WORKING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A BAD EKI BOARD AND THE K1 HYBRID ARM VALUE WAS INCORRECT.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED OBTAINING ERROR 3012: PRETREATMENT REAGENT SHORTAGE AND ERROR 2081: SPECIMEN SHORTAGE DETECTED WITH THEIR AIA-2000 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN E2, FSH AND LH-II PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF E2, 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
    207067 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1