BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7361019 · Received March 22, 2018

    Report

    Report Number
    8031673-2018-02974
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    May 9, 2017
    Report Date
    March 22, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 9 MAY 2017. THE FSE INSPECTED AND TESTED THE ENTIRE INSTRUMENT AND ONLY FOUND SOME WASH DEBRI IN THE INCUBATOR. THE ENGINEER CLEANED THE DEBRIS AND RAN DAILY QC WHICH PASSED WITH NO ERRORS. THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS WASH DEBRIS IN THE INCUBATOR

    Description of Event or Problem · 0

    ON 9 MAY 2017 TECHNICAL SUPPORT (TS) SPOKE TO THE CUSTOMER. THE CUSTOMER REPORTED THEY RUN BR QC MATERIAL 40320 FOR PROSTATE-SPECIFIC ANTIGEN (PSA) AND THE QUALITY CONTROL (QC) IS NEVER AN ISSUE WITH THEIR AIA-900 ANALYZER. THE CUSTOMER REPORTED QC WAS RUN AND WAS WITHIN RANGE ON (B)(6) 2017. REPORTEDLY ON (B)(6) 2017 THE CUSTOMER RAN A PSA PATIENT SAMPLE AND GOT 0.62 AS A PATIENT RESULT, WHICH WAS SUBMITTED TO THE PHYSICIAN. THE PHYSICIAN RETURNED THE RESULT CLAIMING IT WAS ELEVATED AND UNEXPECTED. THE CUSTOMER SPLIT THE PATIENT SAMPLE AND SENT IT OUT TO A REFERENCE LABORATORY, THE LABORATORY RESULT WAS <0.07. THE CUSTOMER FROZE THE PATIENT SAMPLE. ON (B)(6) 2017 THE CUSTOMER RAN QC FOR PSA AND THEN UNFROZE THE SAME PATIENT SAMPLE AND RE-RAN THE PSA AND THE RESULT WAS <0.05, THIS TIME NOW AGREEING WITH THE REFERENCE LABORATORY AND THE PHYSICIANS EXPECTED VALUE. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING FSH AND IPTH PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205820 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1