BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 477524 · Received August 4, 2003

    Report

    Report Number
    1628664-2003-00014
    Event Type
    Other
    Date Received
    August 4, 2003
    Date of Event
    July 14, 2003
    Report Date
    August 1, 2003
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE IMX GENERATED A B-HCG PAITENT SAMPLE RESULT OF 85,000 IU/L WHEN RUN IN THE 1:200 DILUTION PROTOCOL. THE BIORAD HI QC RESULT WAS OUT OF RANGE LOW FOR THE SAME RUN. THE CUSTOMER REPEATED THE RUN AND ALL QC WERE IN RANGE. THE REPEAT RESULT WAS 25,000 IU/L. THE CUSTOMER PERFORMED AN ASSAY CALIBRATION AND RAN THE PATIENT SAMPLE IN DUPLICATE IN THE DILUTION PROTOCOL. THE RESULTS WERE 29,844 AND 50,898 IU/L. THE CUSTOMER REPORTED THE 25,000 IU/L RESULT. THE REPORTED RESULT WAS NOT QUESTIONED. PATIENT INFORMATION IS NOT AVAILABLE. THE B-HCG REAGENT (01A06-22) WAS LOT # 03347Q100. THE QC LOT AND QC VALUES WERE NOT PROVIDED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IMX BHCG REAGENT LIST NO. 1A06-22 LOT NO.03347Q100