BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7333983 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-01671
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    December 21, 2016
    Report Date
    March 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE WHERE HE CLEANED AND LUBRICATED THE CUP PRESENCE SENSOR, RE-ALIGNED THE INTERNAL COMPONENTS OF THE CUP TRANSFER ASSEMBLY, RE-INSTALLED AND VERIFIED ALL THE CUP TRANSFER ALIGNMENTS. ALSO, THE FSE APPLIED TECH BULLETIN T104. THEN, THE CUSTOMER RAN CALIBRATIONS WITHOUT OBTAINING ANY ERRORS. AFTER THE SERVICE, THE AIA 900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A STICKING PRESENCE SENSOR. 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 (B)(6) 2016, A CUSTOMER REPORTED ERROR 2163: C-TRANS CUP NOT RELEASED ISSUES WITH THEIR AIA 900 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN PROLACTIN AND PTH PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PROLACTIN AND PTH 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
    176232 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1