BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7396609 · Received April 4, 2018

    Report

    Report Number
    8031673-2018-03376
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    June 7, 2017
    Report Date
    April 4, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 7-JUN-2017, AN FSE VISITED THE CUSTOMER SITE, FOUND CORROSION AT CABLE ENTRY TO THE SUBSTRATE SYRINGE DRIVE (PM501), AND REPLACED PM501. ALSO FOUND CORRODED PIN AT THE CABLE CONNECTION FROM THE DRIVER BOARD AND REPAIRED CABLE CN216 TO PM501. THEN PERFORMED A DAILY PROCEDURE AND RAN QUALITY CONTROLS, ALL WITHIN SPECIFICATIONS AND WITHOUT ISSUES. THE INSTRUMENT WAS WORKING AS INTENDED. NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE PULSE MOTOR 501 SUBSTRATE SYRINGE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A CUSTOMER REPORTED OBTAINING SUBSTRATE HOME NOT FOUND ERRORS WITH THEIR AIA-360 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN TROPONIN AND BETA-HCG PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF TROPONIN AND BETA-HCG 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
    238966 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1