BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CMV-G REAGENT KIT

    MDR report key: 851330 · Received May 11, 2007

    Report

    Report Number
    1415939-2007-00030
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    April 20, 2007
    Report Date
    April 20, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFZ
    PMA / PMN Number
    K953943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ONE DONOR SAMPLE GENERATED AN INITIAL AXSYM CMV IGG ASSAY RESULT OF 0.0 AU/ML (NEGATIVE). THE SAMPLE RETESTED AT 69.8 AND 88.1 AU/ML (POSITIVE) AFTER CENTRIFUGATION. CONTROLS WERE WITHIN SPECIFICATIONS. THE SAMPLE GENERATED A POSITIVE RESULT (76.8 AU/ML) ON THE ARCHITECT I2000 PLATFORM (AFTER CENTRIFUGATION THE SAMPLE RETESTED WITH RESULTS OF 76.1 AND 82.6 AU/ML). LABORATORY PERSONNEL NOTED THAT THEY DID NOT THINK THE AXSYM ANALYZER ASPIRATED THE CORRECT SAMPLE VOLUME AND MAY HAVE ASPIRATED AIR; HOWEVER, THE AXSYM ANALYZER GENERATED NO ERROR MESSAGES AT ANY TIME DURING THE TESTING OF THIS SAMPLE. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CMV-G REAGENT KIT IN VITRO DIAGNOSTIC TEST KIT OR THE DETECTION OF CMV ANTIBODIES LFZ ABBOTT LABORATORIES NA 46194M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR AXSYM ANALYZER LIST#: 7A83-01