BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7361722 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-03221
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 2, 2016
    Report Date
    March 22, 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

    ON (B)(6) 2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THE FSE FOUND THE ASSAY AT LOW RANGE IN TEST FILES WHICH IS INCORRECT FOR #BMG. THE FSE CHANGED THE ASSAY L RANGE TO CORRECT THE VALUE AND RAN QC AND NOW NO <L ANSWERS FOR L1 QC. THE CUSTOMER STATES THERE IS NO #BMG IN LEVEY JENNINGS WHEN IT IS LISTED UNDER QC MATERIAL. THE FSE INFORMED THE CUSTOMER THE LEVEY JENNINGS MUST HAVE A DATA POINT BEFORE IT WILL HAVE A SELECTION FOR A LEVEY JENNINGS CHART. THE CUSTOMER STATES THE UNIT IS SKIPPING BARCODES-THE UNIT IS READING THE BARCODES FINE BUT SAYS THERE IS NOT TEST REQUESTED FOR THAT BARCODE. THE FSE DETERMINED THE LIS AND THE UNIT ARE NOT SET UP PROPERLY. THE CUSTOMER STATES WILL REVIEW AND HAVE THE STAFF HELP WITH THIS ISSUE. THE FSE INSTRUCTED THE CUSTOMER ON WHERE THE SETTING IS TO HELP CORRECT THE ISSUE. THE FSE RAN THE MACRO FOR GET A TIP FROM ALL 4 CORNERS OF ALL TIP BOXES WITH NO ERRORS AND INSTRUCTED THE CUSTOMER ON HOW THE TIPS ARE PICKED UP. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 IS FUNCTIONING AS INTENDED WITH ALL ISSUES CLEARED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE ASSAY RANGE FOR #BMG WAS ENTERED INCORRECTLY. TOSOH BIOSCIENCE, INC. IS SUBMITTNG 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 (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED ERROR MESSAGE 2207 (NO TIP ACQUIRED BY SORTER) ON THE AIA-2000. THE CUSTOMER STATES THAT 532 TIPS REGISTERED, HOWEVER, EARLIER HAD NO TIP ACQUIRED BY SORTER. THE CUSTOMER CAN SEE THE TIP IS BEING PICKED UP. TECHNICAL SUPPORT (TS) TRIED TO TROUBLESHOOT WITH THE CUSTOMER AND REQUESTED THE CUSTOMER TO RUN ONE TEST. THE CUSTOMER STATES THAT CAN SEE ONE DROP OF SAMPLE AT THE END OF THE TIP. THE TS ALSO ASKED THE CUSTOMER TO RUN ONE TEST TO SEE IF <L. THE CUSTOMER WANTED TO KNOW IF THE ANALYZER CAN BE RUN TONIGHT. TS RECOMMENDED IF THE CUSTOMER IS GETTING <L ON EVERYTHING THAT THE CUSTOMER SHOULD NOT RUN, IF A RUN CAN BE DONE TO RUN QC AT BEGINNING, MIDDLE AND END OF RUN. THE CUSTOMER ALSO REPORTED AN ISSUE WITH BARCODES SKIPPING. THE CUSTOMER IS UNABLE TO RUN AFP, BHCG, FSH, LH, AND E2 PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING AFP, BHCG, FSH, LH, AND E2 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
    205920 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1