BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000ST

    MDR report key: 7369552 · Received March 26, 2018

    Report

    Report Number
    8031673-2018-03416
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    August 4, 2015
    Report Date
    March 26, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO CONDUCTED FOLLOW-UP WITH THE CUSTOMER WHO FOUND SCREWS ON EKI BOARD COVER WERE LOOSE.FSE TIGHTENED AND INSPECTED ALL. RAN 2 TT3 CALIBRATIONS IN TOSOH CUPS WITH NO ERRORS.NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A LOOSE SCREWS ON EKI BOARD, BAD GROUND CONNECTION 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) 2015, A CUSTOMER REPORTED ERROR 2066 FALSE DETECTION OF SPECIMEN WITH THEIR AIA-2000 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 04-AUG-2015 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
    213588 AIA-2000ST AIA-2000ST KHO TOSOH CORPORATION AIA-2000ST

    Patients

    Seq Age Sex Outcome Treatment
    1