BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7382500 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-04453
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    June 27, 2017
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 29-JUN-2017, THE FSE NOTED THAT THERE WAS NO EVIDENCE OF BURNING PARTS OR SMELL WHEN THE INSTRUMENT WAS INSPECTED AT THE CUSTOMER'S SITE. THE FSE REPLACED A DEFECTIVE Y-AXIS MOTOR AND SORT BOARD, AND ALIGNED THE SORTER ASSEMBLY. SORTER AND MICRO CHECKS WERE RUN AND THE CUSTOMER RESUMED OPERATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A DEFECTIVE Y-AXIS MOTOR AND SORT BOARD.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE CUSTOMER REPORTED RECEIVING ERROR 4041, SORTER Y-AXIS HOME DETECTION FAILURE, ON THEIR AIA-2000 ANALYZER. THE ERROR PERSISTED AFTER RUNNING AN ALL SET HOME FUNCTION, REMOVING THE RACK LOADER, AND REBOOTING THE ANALYZER. AS REPORTED, A BURNING SMELL ACCOMPANIED THE ISSUE. NO INJURY, MALFUNCTION, OR FIRE/SMOKE WAS REPORTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH MAY HAVE RESULTED IN DELAYED REPORTING OF E2 AND BHCG PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224274 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1