BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIA-600 II

    MDR report key: 575604 · Received January 24, 2005

    Report

    Report Number
    2950409-2005-00016
    Event Type
    Injury
    Date Received
    January 24, 2005
    Date of Event
    December 27, 2004
    Report Date
    January 5, 2005
    Manufacturer
    TOSOH CORP.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS FALSE POSITIVE RESULT ON CTNI WHICH UPON REPEAT GAVE RESULTS OF <L (LESS THAN 0.06 NG/ML).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization