BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 516366 · Received January 23, 2004

    Report

    Report Number
    1628664-2004-00002
    Event Type
    Other
    Date Received
    January 23, 2004
    Date of Event
    December 15, 2003
    Report Date
    January 20, 2004
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AN AXSYM BHCG RESULT OF 1,385 MIU/ML WAS REPORTED ON A PREGNANT PT IN 2003. THE PHYSICIAN THOUGHT THE PT MAY BE EXPERIENCING A MISCARRIAGE BECAUSE THE PT'S PREVIOUS BHCG RESULT WAS 40,637 MIU/ML. THE PT WAS REDRAWN A WEEK LATER WITH A BHCG RESULT OF 89,885 MIU/ML. THE SAMPLE FROM THE PREVIOUS WEEK WAS THEN RETESTED YIELDING A RESULT OF 62,737 MIU/ML. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AXSYM TOTAL BHCG LOT NO. 09439Q100.