BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7410129 · Received April 9, 2018

    Report

    Report Number
    8031673-2018-04951
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    June 10, 2016
    Report Date
    April 9, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K0971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 10-JUN-2016, FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. FSE PERFORMED ALL SORTER TIP AND HYBRID ARM NOZZLE ALIGNMENTS; THEN, VERIFIED THE DEVICE WAS FUNCTIONAL BY RUNNING MACROS, VITAMIN D, CALIBRATION, AND CONTROLS. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO SORTER TIP MISALIGNMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE CUSTOMER REPORTED INTERMITTENT TIP DETACH ERROR WITH THEIR A1A-2000ST. ON (B)(4) 2016, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH MAY HAVE RESULTED IN DELAYED REPORTING OF AFP 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
    250698 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1