BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7343262 · Received March 15, 2018

    Report

    Report Number
    8031673-2018-03122
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    April 14, 2016
    Report Date
    March 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 25-APR-2016, FSE FOLLOWED UP WITH THE CUSTOMER TO TROUBLESHOOT THE REPORTED EVENT. THE DEVICE SUBSTRATE STILL WAS NOT SWITCHING FROM SUBSTRATE #1 TO SUBSTRATE #2. THE FSE REPLACED THE LQD BOARD AND 3-WAY SOLENOID VALVE. THE DEVICE WAS RESTARTED AND TESTED WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAULT/FAILURE OF THE LQD BOARD.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED ISSUES WITH SUBSTRATE VOLUME ACCURACY WITH THEIR AIA-2000. HE WAS NOT RECEIVING THE WARNING INFORMING THE SUBSTRATE WAS LOW AND THEN SWITCHES TO THE SECOND BOTTLE. AFTER REVIEWING THE SPECIFICATIONS, THE CUSTOMER NOTED THAT THE SETTINGS WERE SET TO WARN AND THE CHECK MARK FOR SUBSTRATE WARNING HAD TWO BOTTLES LOADED; ONE WAS HALF FULL AND THE OTHER WAS ALMOST EMPTY. THE DEVICE DISPLAY SHOWED THE SECOND BOTTLE. ON (B)(6) 2016, THE CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) WITH CONTINUED SUBSTRATE ISSUES. HE REPORTED RECEIVING THE WARNING THAT THE DEVICE HAD SWITCHED TO AND WAS USING SUBSTRATE #2. WHEN HIS RESULTS WERE REPORTING, HE RECEIVED THE (DL) FLAG CAUSING HIM TO CHECK AGAIN. HE NOTED THAT SUBSTRATE #1 BOTTLE WAS COMPLETELY EMPTY. THE CUSTOMER REPORTED THAT THE LINES APPEARED OK AND WERE FREE FROM AIR AND KINKS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BHCG REPRODUCTIVE HORMONE, LUTEINIZING HORMONE (LHII),PROLACTIN (PRL) AND FOLLICLE STIMULATING HORMONE (FSH) 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
    185000 AIA-2000 AIA-2000ST KHO TOSOH CORPORATION AIA-2000ST

    Patients

    Seq Age Sex Outcome Treatment
    1