BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8951290 · Received August 30, 2019

    Report

    Report Number
    8031673-2019-00314
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 2, 2019
    Report Date
    May 4, 2020
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEST CUP PICKING ASSEMBLY (PART# 022965) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING CONFIRMED THE REPORTED ISSUE WAS DUE TO FAILURE OF THE TEST CUP PICKING ASSEMBLY AS THE Z AXIS MOTOR WOULD NOT MOVE AND A Z AXIS ERROR OCCURRED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. UPON ARRIVAL THE INSTRUMENT REPRODUCED ERROR 4151 DURING START UP. THE CUP TRANSFER ASSEMBLY WAS REPLACED, AND CUP TRANSFER TEST WAS EXECUTED 20 TIMES IN ORDER TO ENSURE RELIABILITY OF REPAIR. THE QUALITY CONTROLS (QC) PASSED AND WERE WITHIN PUBLISHED BIO-RAD RANGES NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 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 02JUL2018 THROUGH AWARE DATE (B)(6) 2019. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: 4151 - C.TRANS-Z HOME DETECT ERROR CAUSE: THE HOME SENSOR S062 FAILED TO BE ACTIVATED AFTER THE TRANSFER Y MOVED TOWARD THE HOME POSITION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S062 AND PM061 FOR A POSSIBLE MALFUNCTION. PER THE INSTRUMENT SERVICE PERFORMED BY THE FSE, THE PROBABLE CAUSE WAS DUE TO A FAILURE OF Z-AXIS SENSOR MOTOR ON THE CUP TRANSFER ASSEMBLY. HOWEVER, FUNCTIONAL TESTING OF THE CUP TRANSFER ASSEMBLY IS PENDING. THE PROBABLE CAUSE CANNOT BE CONFIRMED UNTIL THE FUNCTIONAL TESTING IS COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGE 4151 C TRANS Z AXIS HOME DETECT ON THE AIA-900 INSTRUMENT. A TECHNICAL SUPPORT SPECIALIST (TSS) HAD THE CUSTOMER CLEAN THE CUP PICKER , SENSOR, AND WASTE CHUTE, REBOOT AND AN ALL SET HOME, WHICH RESULTED IN ERROR 4151. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF ESTRADIOL (E2), AND LUTEINIZING HORMONE (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
    745300 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1