BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 966053 · Received December 18, 2007

    Report

    Report Number
    1628664-2007-00591
    Event Type
    Other
    Date Received
    December 18, 2007
    Date of Event
    October 30, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A NEGATIVE AXSYM CMV LGG RESULT OF 4.1 IU/ML WAS GENERATED ON A PT SAMPLE THAT RETESTED POSITIVE (168.6 IU/ML) ON THE SAME AXSYM ANALYZER. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR