BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7918186 · Received September 28, 2018

    Report

    Report Number
    8031673-2018-05211
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    January 31, 2017
    Report Date
    September 28, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. H3 EVALUATION SUMMARY FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE REPLACED THE STC LANE ASSEMBLY WHICH INCLUDED THE MIXER ASSEMBLY. FSE PERFORMED ALIGNMENTS OF THE SEAL BREAKER, Y-AXIS CUP TRANSFER, AND THE SORTER TO STC LANE AND RT LANE. FSE THEN RAN THE GET UP MACRO, GET TIP MACRO, AND THE CUP EVALUATION MACRO WITHOUT ANY ISSUES. THE QUALITY CONTROLS WERE RUN WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE AIA-2000 OPERATOR'S MANUAL STATES THE FOLLOWING IN APPENDIX 4: [3061] STC LANE MIXING FAILURE CAUSE : THE MIXING CHECK SENSOR OF THE STC LANE MIXING MOTOR FAILED TO DETECT A MIXING OPERATION. THE CURRENT MEASUREMENT WILL BE FLAGGED (IO FLAG) AND NEW MEASUREMENTS WILL BE SUSPENDED. SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS FAILURE OF THE STC LANE MIXER.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 3061 STC LANE MIXING FAILURE MESSAGE WITH THE AIA-2000ST ANALYZER. THE CUSTOMER WAS NOT ABLE TO PERFORM AN ALL SET HOME NOR PERFORM A VERSION UP. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH COULD HAVE RESULTED IN DELAY OF PARATHYROID HORMONE (PTH) AND PROGESTERONE (PROG) PATIENT RESULTS. 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
    761186 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1