BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1A-2000

    MDR report key: 7404685 · Received April 6, 2018

    Report

    Report Number
    8031673-2018-04489
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    September 7, 2016
    Report Date
    April 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 08-SEP-2016, AN FSE VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE REPLACED THE LEAK SENSOR AND ADJUSTED THE TIP SENSOR. THE INSTRUMENT WAS VERIFIED AS OPERATIONAL. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE LEAK SENSOR UNDER THE BF UNIT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED ERROR 3005 (LEAK SENSOR ERROR) WITH THEIR A1A-2000 ANALYZER. THE CUSTOMER REPORTED THAT THE ERROR WAS PREVIOUSLY FIXED BUT WHEN IT OCCURRED THIS TIME, IT DID NOT ABORT HER RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING ALPHA FETOPROTEIN (AFP) AND BETAHCG (PREGNANCY HORMONE) 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
    245097 A1A-2000 A1A-2000 KHO TOSOH CORPORATION A1A-2000

    Patients

    Seq Age Sex Outcome Treatment
    1