BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7368567 · Received March 24, 2018

    Report

    Report Number
    8031673-2018-02981
    Event Type
    Malfunction
    Date Received
    March 24, 2018
    Date of Event
    December 12, 2016
    Report Date
    March 24, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: ON 13-DEC-2016, AN FSE CONDUCTED ON-SITE FOLLOW-UP WITH THE CUSTOMER. THE FSE ATTEMPTED TO VERIFY THE INTERMITTENT 3002 AND 3003 ERRORS, BUT WAS UNABLE TO DUPLICATE THEM. AS PREVENTIVE MEASURE THE LQD BOARD WAS REPLACED. THE FSE VERIFIED THE INSTRUMENT SENSORS AND PROPER OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE LQD BOARD.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED THE ERROR 3002 SUBSTRATE SHORTAGE DETECTED UPON START-UP AND SHUTDOWN AND WASTE FULL WHEN THE WASTE IS EMPTY WITH THEIR AIA-900 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 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
    211458 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1