BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7323743 · Received March 8, 2018

    Report

    Report Number
    8031673-2018-02404
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    April 10, 2017
    Report Date
    March 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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-APRIL-2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE FSE INSPECTED THE CUP TRANSFER UNIT AND INCUBATOR THEN FOUND THE INCUBATOR WAS OUT OF ALIGNMENT DUE TO A BELT SLIP. THE FSE READJUSTED AND TIGHTENED THE TENSION ON THE BELT AND PERFORMED ALIGNMENTS FOR THE INCUBATOR. THE FSE VERIFIED THE ALIGNMENT POSITIONING FOR SUBSTRATE, BF WASH PROBES, CUP TRANSFER, AND SPECIMEN NOZZLE. THE FSE PERFORMED A CUP TRANSFER MACRO AND REMOVED ALL CUPS MACRO. ALL TESTS PASSED. THE FSE RAN QUALITY CONTROLS (QC). ALL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE AIA-900 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR ERROR 2161 C. TRANSFER CUP PICKUP FAILURE WAS THE INCUBATOR BELT WAS LOOSE AND CAUSING THE BELT SLIP

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED ERROR 2161 C. TRANSFER CUP PICKUP FAILURE ON THE AIA-900 INSTRUMENT. THE CUSTOMER CONDUCTED AN ALL SET HOME FUNCTION AND THE SYSTEM OPERATED AS INTENDED. THE WASTE CHUTE WAS NOT BACKED UP. WHEN THE CUSTOMER TRIED TO RUN QUALITY CONTROLS, THE ERROR APPEARED. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON BHCG REPRODUCTIVE HORMONE, PROLACTIN (PRL), FOLLICLE STIMULATING HORMONE (FSH), ESTRADIOL (E2), AND LUTEINIZING HORMONE (LHII). ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BHCG, PRL, FSH, E2, AND LHII. 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
    168671 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1