BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 666481 · Received January 20, 2006

    Report

    Report Number
    1628664-2006-00008
    Event Type
    Other
    Date Received
    January 20, 2006
    Date of Event
    December 23, 2005
    Report Date
    January 18, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT STATES A PT GENERATED ARCHITECT B-HCG RESULTS OF 1.6 AND 1.4 IU/L. THE CONTROLS WERE WITHIN RANGE PRIOR TO RUNNING THE PT SAMPLE. CONTROL RESULTS WERE LATER OUT OF RANGE LOW; THE ACCOUNT REPLACED THE WASH BUFFER AND CONTROLS CAME BACK INTO RANGE. THE PT SAMPLE WAS RETESTED THE FOLLOWING DAY WITH A NEAT RESULT OF >15,000.0 IU/L AND A DILUTED RESULT OF 33,468.2 IU/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN