BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 704130 · Received April 21, 2006

    Report

    Report Number
    1628664-2006-00021
    Event Type
    Other
    Date Received
    April 21, 2006
    Date of Event
    April 3, 2006
    Report Date
    April 4, 2006
    Manufacturer
    ABBOTT LABORATORIES, INC
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AXSYM TOTAL BHCG RESULTS OF 198.32 AND 3961.44 MIU/ML (BOTH TESTED 1:10 AUTODILUTED ON APRIL 3, 2006) WERE GENERATED ON THE SAME PATIENT SAMPLE. THE RESULT OF 3961.44 MIU/ML WAS REPORTED BASED ON PATIENT HISTORY. THE PATIENT IS EIGHT WEEKS PREGNANT AND THE PREVIOUS BHCG RESULT WAS 1500 MIU/ML. THE SAMPLE QUESTION RETESTED AT 3268.23 MIU/ML TWO DAYS LATER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other