BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7298564 · Received February 26, 2018

    Report

    Report Number
    8031673-2018-02202
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    May 9, 2016
    Report Date
    February 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE CONFIRMED IMPRECISION FOR THE E2 ASSAY. THE FSE DECONTAMINATED THE WASH SUBSTRATE AND DILUENT THEN MADE FRESH WASH DILUENT AND SUBSTRATE. IN ADDITION, THE FSE REPLACED THE WASH PROBE ASSEMBLY, 2-WAY SOLENOID WASTE VALVE, 3-WAY SOLENOID WASHER VALVE, SPECIMEN DISPENSE SYRINGE ASSEMBLY AND SAMPLING NOZZLE ASSEMBLY. FOLLOWING, TT3 PRECISION NOW 1.5% CV AND E2 PRECISION NOW 3.5% CV. REVIEW OF SERVICE AND COMPLAINT HISTORY FOR SERIAL NUMBER 10212811 WAS CONDUCTED FROM 09-APRIL-2015 THROUGH 09-MAY-2016 FOR SIMILAR COMPLAINTS AND IDENTIFIED NO SIMILAR TYPE OF EVENT. THE MOST PROBABLE CAUSE OF THIS EVENT MAY BE RELATED TO FAILURE OF THE WASH SUPPLY VALVE. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2016 THE CUSTOMER REPORTED E2 PRECISION ERRORS WITH USE OF THE AIA-900 ANALYZER. THE CUSTOMER REPORTED THAT THE PATTERN OF RESULTS STARTED LOW AND INCREASED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR E2. THERE IS 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
    141244 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1