BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CMV-G REAGENT KIT

    MDR report key: 969349 · Received July 13, 2006

    Report

    Report Number
    1415939-2006-00015
    Event Type
    Other
    Date Received
    July 13, 2006
    Date of Event
    July 3, 2006
    Report Date
    July 3, 2006
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE ISSUED AT THE CONCLUSION OF AN INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN AXSYM CMV LGG ASSAY RESULT OF 0.0 AU/ML. THE SAMPLE TESTED CMV LGG POSITIVE ON A COMPETITOR'S PLATFORM. THE CUSTOMER RETESTED THE SAMPLE WITH THE AXSYM CMV LGG ASSAY AND GENERATED A POSITIVE RESULT OF 153.9 AU/ML. CONTROLS WERE WITHIN SPECIFICATIONS. THE CUSTOMER STATES THAT THE ANALYZER AND ASSAY ARE PERFORMING WITHIN SPECIFICATIONS. THERE IS NOT IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CMV-G REAGENT KIT IN VITRO TEST KIT FOR CMV ANTIBODIES LFZ ABBOTT LABORATORIES NA 34152M100

    Patients

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