BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7335164 · Received March 13, 2018

    Report

    Report Number
    8031673-2018-02460
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    August 24, 2016
    Report Date
    March 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. TECHNICAL SUPPORT FOUND THAT THE ERROR WAS CAUSED BY PRETREATMENT. WHEN THE CUSTOMER MADE FRESH PRETREATMENT, THE ERRORS CLEARED. THE CUSTOMER HAD THE SOFTWARE ISSUE WHICH WAS RESOLVED BY CHANGING SPECS. THE MOST PROBABLE CAUSE OF PATIENT FOLATE SAMPLE RESULTS WERE HIGH WAS PRETREATMENT VOLUME OR QUALITY.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED PATIENT FOLATE SAMPLE RESULTS WERE HIGH AND THE PATIENT SAMPLE (PS) FLAG WAS INDICATED ON THE AIA-900 INSTRUMENT. ALL CONTROLS AND TWO PATIENT SAMPLES WERE IN RANGE. THE CUSTOMER WAS INSTRUCTED TO REPEAT SAMPLES AND CONTROLS. MAC CONTROLS AND ADDITIONAL TEST CUPS WERE SENT TO THE CUSTOMER. THERE IS 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
    177677 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1