BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7398644 · Received April 5, 2018

    Report

    Report Number
    8031673-2018-04748
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    August 8, 2016
    Report Date
    April 5, 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

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 8 AUGUST 2016. THE FSE REPLACED THE WASH PUMP AND PERFORMED PREVENTIVE MAINTENANCE. THE ENGINEER BLEACHED THE SYSTEM AND RAN PRECISION, WHICH WAS IN SPECIFICATION UPON COMPLETION OF THE BLEACHING. THE AIA 360 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS THE WASH PUMP

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED A WASH PUMP ISSUE WITH THEIR AIA 360 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING FSH, E2 AND LHII PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242744 AIA-360 AIA-360, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1