BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7352014 · Received March 20, 2018

    Report

    Report Number
    8031673-2018-01293
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    May 11, 2015
    Report Date
    March 19, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON (B)(6) 2015 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE CLEANED SAMPLE NOZZLE ASSEMBLY AND WAS LUBRICATED. FSE IS STILL HEARING A GRINDING NOISE IN THE INSTRUMENT. FSE REPLACED THE DRIVER BOARD AND RAN DAILY CHECKS. THE CUSTOMER RAN QUALITY CONTROLS AND ALL RESULTS WERE WITHIN SPECIFICATION. INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAULTY DRIVER BOARD. 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) 2015 A CUSTOMER REPORTED ERROR 4019 SPEC.Z-AXIS HOME NOT FOUND WITH THEIR AIA-360 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING 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
    195969 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1