BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7333260 · Received March 12, 2018

    Report

    Report Number
    8031673-2018-01258
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    October 7, 2015
    Report Date
    March 12, 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

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(6) 2015 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE FOUND B/F WASH PROBE HAS INTERMITTENT ERROR. FSE REPLACED THE PULSE CABLE THEN DIEP THE MT ON THE 2000 STATION. A CONTROL RUN WAS PERFORMED AND RESULTS WERE WITHIN SPECIFICATION. INSTRUMENT IS FUNCTIONING AS INTENDED AND RELEASED. THE MOST PROBABLE CAUSE FOR THIS EVENT IS THE WASH PROBE 1 PULSE CABLE. 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-(B)(4).

    Description of Event or Problem · 0

    ON THE (B)(6) 2015 THE CUSTOMER REPORTED ERROR 4443 B/F PROBE 1 HOME OVERRUN , 2050 SCHEDULER CONTROL START DELAY AND 2043 B/F WASH CONTROL START DELAY ON THEIR AIA-2000. CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE REPORTED ISSUE WHICH RESULTED IN DELAY REPORTING OF RESULTS FOR PTH, BHCG, PRL, PROG AND LHII. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175903 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1