BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7423915 · Received April 11, 2018

    Report

    Report Number
    8031673-2018-03392
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    November 14, 2016
    Report Date
    April 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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. ON 16-NOV-2016, AN FSE VISITED THE CUSTOMER FACILITIES AND CHECKED THE INSTRUMENT'S ERROR LOG. THE LOG SHOWED A FREQUENT HYBRID-ARM CUP TRANSFER ERRORS AND SAMPLE CLOGGING ERRORS. NO NO-TIP ACQUIRED BY SORTER ERRORS WAS OBSERVED. THE FSE ADJUSTED ALL REQUIRED HYBRID ARM CUP TRANSFER POINTS, REPLACED THE OBSERVED BROKEN SAMPLE NOZZLE AND EKI BOARD ON THE MAIN ARM. INSTRUMENT WAS WORKING AS INTENDED AT THAT MOMENT. ON 17-NOV-2016, THE FSE RETURNED TO THE CUSTOMER LOCATION BECAUSE THE CUSTOMER CALLED ABOUT SIMILAR ISSUES. THE FSE DISCOVERED PROBLEMS WITH THE MAIN ARM SAMPLING AND WITH THE SORTER. THE FSE COMPLETED THE REPAIR OF SAMPLE NOZZLE, EKI BOARD AND SORTER, THEN TESTED THE EKI/SAMPLE BOARD REPAIR MULTIPLE TIMES, AND MONITORED FOR STEADY LIQUID LEVEL SENSING AND PRESSURE DETECTION (CLOGGING). THE INSTRUMENT WAS FUNCTIONING CORRECTLY. CUSTOMER RAN CONTROLS & PATIENTS SUCCESSFULLY. A REVIEW OF COMPLAINT HISTORY FOR THE NEXT THREE (3) MONTHS AFTER THIS TICKET DID NOT IDENTIFY ANY FURTHER ASSISTANCE REQUESTED BY THE CUSTOMER RELATED TO THE OBSERVED 2151AND 2207 ERRORS, THEREFORE, NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A DEFECTIVE SAMPLE NOZZLE.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED OBTAINING MULTIPLE ERROR CODES INCLUDING 2151: HYBRID ARM-CUP TRANSFER CUP PICKUP FAILURE AND 2207: NO TIP ACQUIRED BY SORTER WITH THEIR AIA-2000 ANALYZER. THESE ERRORS CAUSE THE ANALYZER TO ABORT THE RUNS. THE CUSTOMER WAS UNABLE TO RUN BETA-HCG AND AFP PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA-HCG AND AFP 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
    265203 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1