BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 8648302 · Received May 28, 2019

    Report

    Report Number
    8031673-2019-00175
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 2, 2019
    Report Date
    July 26, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PART RETURNED TO THE MANUFACTURER FOR EVALUATION ON 20-MAY-2019.

    Additional Manufacturer Narrative · 0

    THE EKI BOARD (PART # 023665) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF THE EKI BOARD AS THE ERROR COULD NOT BE DUPLICATED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS NOT IDENTIFIED AS THE ISSUE COULD NOT BE DUPLICATED DURING FUNCTIONAL TESTING OF THE RETURNED PART.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE FSE CONFIRMED THE COMPLAINT BY VERIFYING THE ERROR LOG AND MONITORING THE INSTRUMENT'S PERFORMANCE DURING A RUN. THE EKI BOARD WAS ADJUSTED TO SPECIFICATIONS AND THE SAMPLING NOZZLE WAS CLEANED AND FLUSHED. THE FSE ALSO PERFORMED AN EKI PRESSURE BOARD ADJUSTMENT. AFTER THE ADJUSTMENTS WERE MADE THE 2072 UNABLE TO PRETREATMENT LEVEL ERROR PERSISTED. PARTS WERE ORDERED AND FSE WILL RETURN TO THE CUSTOMER SITE TO FINISH REPAIRS. UPON THE FOLLOWING FSE ONSITE SERVICE, THE EKI BOARD WAS REPLACED DUE TO POSSIBLE INTERMITTENT OPERATION. THE FSE VERIFIED ALL SPECIMEN Z-AXIS ALIGNMENTS, CLOT, AND LEVEL DETECTION. THE SPECIMEN Z-AXIS LEAD SCREW, INCUBATOR ROTOR, AND BASEPLATE WAS CLEANED/LUBRICATED. THE FSE RAN A MOCK RUN OF 40 SPECIMENS TO VERIFY PROPER SAMPLING WHICH RAN WITHOUT ERRORS. DAILY MAINTENANCE AND #TT3 QUALITY CONTROL (QC) WERE RAN WITHOUT ERROR. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-900 INSTRUMENT IS FUNCTIONING AS EXPECTED. THE AIA-900 ANALYZER, SERIAL NUMBER (B)(4), WAS INSTALLED AT THE ACCOUNT ON 29-NOV-2018. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 29-NOV-2018 THROUGH AWARE DATE 02-MAY-2019. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: 2072 - UNABLE TO PRETREATMENT LEVEL. CAUSE: THE LIQUID LEVEL WAS DETECTED BEFORE IT REACHED THE LEVEL OF THE PRETREATMENT LIQUID. AN ES FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: IF THE TROUBLE REOCCURS, CONTACT THE TOSOH LOCAL REPRESENTATIVES. 2076 - CLOGGING DETECTED AT SPECIMEN. CAUSE: THE NEGATIVE PRESSURE GENERATED BY SUCTION OF A[?] RACK ID, RACK, POSITION, SPECIMEN ID[?] SPECIMEN EXCEEDED THE STANDARD VALUE. THERE IS A POSSIBILITY THAT THE SAMPLING NOZZLE WAS CLOGGED, PREVENTING THE SPECIFIED QUANTITY OF SPECIMEN SUCTION FROM TAKING PLACE. AN SC FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: IF THERE IS NO PROBLEM WITH THE SPECIMEN, CONTACT THE TOSOH LOCAL REPRESENTATIVES. 4124 - SAMPLE-Z BUMP. CAUSE: THE SPECIMEN CAP REAR-END COLLISION SENSOR S054 WAS ACTIVATED WHILE THE SPECIMEN DISPENSING ARM Z WAS MOVING TOWARD THE HOME POSITION. A SS FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: IF THE CAP IS ON THE SPECIMEN, REMOVE IT AND PERFORM MEASUREMENT ONCE AGAIN. IF IT IS NOT, CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S054 AND PM051 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO A FAULTY EKI BOARD.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGES 2072 UNABLE TO PRETREATMENT LEVEL, 2076 CLOGGING DETECTED AT SPECIMEN, AND 4124 SAMPLE-Z BUMP ON THE AIA-900 INSTRUMENT. 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
    439862 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1