BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7331623 · Received March 12, 2018

    Report

    Report Number
    8031673-2018-02440
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    October 10, 2016
    Report Date
    March 12, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 10-OCTOBER-2016, A CUSTOMER SERVICE SUPPORT (CSS) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. THE CSS PROVIDED TRAINING TO THE CUSTOMER AND CORRECTED PROCEDURAL ERRORS. THE AIA-900 INSTRUMENT IS OPERATIONAL. NO FURTHER ACTION IS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE FOR ALL >H ON PATIENT SAMPLES WAS THE HETER BLOCK WAS ON THE INCORRECT TEMPERATURE.

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED ALL >H ON PATIENT SAMPLES ON THE AIA-900 INSTRUMENT. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO RECALIBRATE IN GLASS TUBES AND THE CURVE WAS FLAT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON HBA1C DIABETES ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174423 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1