BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 9158839 · Received October 4, 2019

    Report

    Report Number
    8031673-2019-00389
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 25, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SORTER X-AXIS MOTOR (PART # 020241) AND SORT BOARD (PART # 022234) WERE RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF THE RETURNED PARTS AS THE ERROR COULD NOT BE DUPLICATED. THE PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE ON TWO SEPARATE OCCASIONS TO ADDRESS THE REPORTED EVENT. ON 9/16/2019. THE FSE WAS ABLE TO CONFIRM THE COMPLAINT BY RUNNING GET CUP MACRO. THE ISSUE WAS REPRODUCED BY WATCHING THE CUP FALL OFF REAGENT /TIP LANE AND RESOLVED BY REPLACING THE SORTER BOARD, DOING A TRAY DRAW ALIGNMENT, AND TIP CUP LANE ADJUSTMENT. ON 9/18/2019, THE FSE WAS ABLE TO CONFIRM THE COMPLAINT BY OBSERVING THAT THE STC CUPS HAD FALLEN INTO STC LANE FROM THE SORTER HEAD WHICH CAUSED AN OBSTRUCTION. THE ISSUE WAS REPRODUCED BY RUNNING MACRO. THE ISSUE WAS RESOLVED BY REPLACING THE PM020 X AXIS SORTER MOTOR. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 13AUG2018 THROUGH AWARE DATE 13SEPT2019 THERE WAS ONE OTHER SIMILAR COMPLAINT IDENTIFIED DURING THE REVIEW PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES STATES THE FOLLOWING: 2150 - HYBRID ARM /CUP TRANSFER CUP DETECTION FAILURE CAUSE : THE CUP-GRIPPING SENSOR FAILED TO DETECT A CUP BEFORE PICKUP. THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG OR SE FLAG). SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. 4121 - STC LANE HOME DETECTION FAILURE CAUSE : THE HOME SENSOR FAILED TO ACTIVATE AFTER THE STC LANE MOVED TOWARD THE HOME POSITION. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION : CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE PM020 X AXIS SORTER MOTOR AND STC CUPS WHICH HAD FALLEN WITHIN THE STC LANE WHICH WAS CAUSED AN OBSTRUCTION OF MOVEMENT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGES 2150 HYBRID ARM/CUP TRANSFER CUP INTERMITTENTLY AND 4121 STC LANE HOME DETECTION FAILURE ON THE AIA-2000 INSTRUMENT. THE CUSTOMER STATED THAT THE HYBRID ARM LANE IS CLEAR AND PERFORMING AN ALL SET HOME COMPLETES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), LUTEINIZING HORMONE (LHII), PROGESTERONE (PROGII), FOLLICLE STIMULATING HORMONE (FSH), AND PROLACTIN (PRL) 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
    950042 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1