BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7422899 · Received April 11, 2018

    Report

    Report Number
    8031673-2018-03394
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    November 11, 2015
    Report Date
    April 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    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 11-NOV-2015, AN FSE VISITED THE CUSTOMER FACILITIES AND FOUND THE CAP DETECTION SENSOR WITH A BROKEN PHOTO-INTERRUPTER. REPLACED AND REALIGNED SUCCESSFULLY. THE INSTRUMENT WAS WORKING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DEFECTIVE PHOTO INTERUPTER B SENSOR BOARD AND A DEFECTIVE A CAP DETECTION SENSOR.

    Description of Event or Problem · 0

    ON (B)(6) 2015, A CUSTOMER REPORTED DETECTING BUBBLES WITH THEIR AIA-2000 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN BETA-HCG, PTH AND PROLACTIN PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA-HCG, PTH AND PROLACTIN 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
    264793 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1