BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7382514 · Received March 29, 2018

    Report

    Report Number
    8031673-2018-04452
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    September 19, 2016
    Report Date
    March 29, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 19-SEP-2016, THE FSE ALIGNED THE DISPENSING LANE TO THE SORTER CUP PICKUP AND RAN MACRO TESTS FOR CUP PICKUPS IN ALL TRAYS WITHOUT ERROR. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS MISALIGNMENT OF THE DISPENSING LANE TO THE SORTER CUP PICKUP.

    Description of Event or Problem · 0

    ON (B)(6) 2016, IT WAS REPORTED THAT THE CUSTOMER'S AIA-2000 ANALYZER WAS DROPPING TEST CUPS AND ABORTING THE RUN. IT WAS ALSO REPORTED THAT CUSTOMER WAS RECEIVING ERROR 4527, PRETREATMENT-DETECTION TABLE ROTATION MOTOR OVERRUN POSITIONING SENSOR ERROR. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH MAY HAVE RESULTED IN DELAYED REPORTING OF FSH, PTH, AND LHII 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
    224495 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1