BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7430647 · Received April 13, 2018

    Report

    Report Number
    8031673-2018-00306
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 16, 2018
    Report Date
    April 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. ON 19-MAR-2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE REMOVED THE CENTER COVER AND NOTICED THE NUT SECURING THE PIPETTOR Z FLAG WAS VERY LOOSE. FSE TIGHTENED THE NUT SECURING THE PIPETTOR Z FLAG. FSE RAN QUALITY CONTROLS (QC); ALL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE AIA-900 INSTRUMENT FUNCTIONS AS INTENDED, THE ERRORS CLEARED. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 16-FEB-2017 THROUGH AWARE DATE 16-MAR-2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERRORS, ERROR 4124 IS SAMPLE-Z BUMP. THIS MESSAGE IS GENERATED WHEN THE SPECIMEN CAP REAR-END COLLISION SENSOR S054 WAS ACTIVATED WHILE THE SPECIMEN DISPENSING ARM Z WAS MOVING TOWARD THE HOME POSITION. A SS (STOP SAMPLING) FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. THE SOLUTION FOR THE CUSTOMER IS 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. ERROR 2066 IS PRETREAT LEVEL DETECT FAILURE. THIS MESSAGE IS GENERATED WHEN THE LIQUID LEVEL WAS NOT DETECTED EVEN WHEN THE TIP WAS LOWERED TO THE BOTTOM OF THE PRETREATMENT REAGENT BOTTLE. AN ES FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. THE SOLUTION FOR THE CUSTOMER IS TO REPLENISH THE PRETREATMENT LIQUID. IF THE TROUBLE REOCCURS, CONTACT THE TOSOH LOCAL REPRESENTATIVES. ERROR 2090 IS NO PRETREAT DETECTED. THE MESSAGE IS GENERATED WHEN THE PRETREATMENT LIQUID WHOSE PRESENCE WAS CONFIRMED DURING THE DISPENSING SCHEDULE WAS EITHER NOT FOUND, OR AN EMPTY PRETREATMENT LIQUID BOTTLE WAS FOUND DURING DISPENSING OF PRETREATMENT LIQUID. THE SYSTEM WILL PROCEED TO ANOTHER BOTTLE. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT AN ES FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. IT IS POSSIBLE THAT THE PRETREATMENT LIQUID WAS REMOVED DURING AN ASSAY. THE SOLUTION FOR THE CUSTOMER IS TO RESET THE PRETREATMENT LIQUID, OR REMOVE THE EMPTY PRETREATMENT LIQUID BOTTLE. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE NUT SECURING THE PIPPETTOR Z INTO SENSOR WAS LOOSE AND STICKY CUP PRESENT SENSOR.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING ERROR 4124 SAMPLE-Z BUMP, 2066 PRETREAT LEVEL DETECT FAILURE , AND 2090 NO PRETREAT DETECTED WHILE RUNNING QUALITY CONTROLS (QC) ON THE AIA-900 INSTRUMENT. CUSTOMER IS UNABLE TO RUN CREATINE KINASE MB ISOENZYME (CK-MB), CARDIAC TROPONIN I (CTNI2), MYOGLOBIN (MYO), AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLES. ON (B)(6) 2018, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR CKMB, CTNI2, MYO, AND BHCG. THERE WAS 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
    271427 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1