BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIA-600II

    MDR report key: 1341373 · Received February 24, 2009

    Report

    Report Number
    3005529799-2009-00001
    Event Type
    Other
    Date Received
    February 24, 2009
    Date of Event
    January 25, 2008
    Report Date
    February 23, 2009
    Manufacturer
    TOSOH CORP.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TOSOH BIOSCIENCE, INC. THAT THE CALIBRATION WAS NOT CORRELATING. THE ACCOUNT STATED THAT THEY HAD TWO AIA-600II ANALYZERS AND ONE IS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIA-600II AUTOMATED IMMUNOASSAY SYSTEM JJE TOSOH CORP. AIA-600II *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other