BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000ST

    MDR report key: 7388735 · Received April 2, 2018

    Report

    Report Number
    8031673-2018-03448
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    January 23, 2017
    Report Date
    April 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO FSE CONDUCTED FOLLOW-UP WITH THE CUSTOMER TO ADDRESS THE REPORTED EVENT. OPERATOR HAD BAD SAMPLES. LEAD TECH CAME IN AND RAN SAMPLES WITH NO ERRORS NOTED. NO FURTHER ACTION FOR THE FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO BAD SAMPLES. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED ERROR 4223 MAIN ARM Z AXIS HOME OVER RUN FAILURE WITH THEIR AIA-2000 ANALYZER A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2017 TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS.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
    231608 AIA-2000ST AIA-2000ST KHO TOSOH CORPORATION AIA-2000ST

    Patients

    Seq Age Sex Outcome Treatment
    1