BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CMV-G REAGENT KIT

    MDR report key: 761898 · Received August 2, 2006

    Report

    Report Number
    1415939-2006-00018
    Event Type
    Other
    Date Received
    August 2, 2006
    Date of Event
    July 19, 2006
    Report Date
    July 19, 2006
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED AN INITIAL AXSYM CMV IGG ASSAY RESULT OF 73.5 AU/ML. THE SAMPLE WAS LATER RETESTED WITH LOT 31293M200 AND GENERATED AN AXSYM CMV IGG ASSAY RESULT OF 0 AU/ML. THE CUSTOMER THEN TESTED THE SAMPLE WITH A THIRD (DIFFERENT) LOT OF REAGENT AND GENERATED AN AXSYM CMV IGG ASSAY RESULT CLOSE TO THE FIRST RESULT OF 73.5 AU/ML (THE CUSTOMER DID NOT GIVE ANY INFO CONCERNING THE OTHER LOTS USED IN TESTING). THE CUSTOMER STATED THAT OVERALL, LOT 31293M200 GENERATES LOWER TEST RESULTS THAN OTHER LOTS USED IN THE LAB. CONTROLS HAVE REMAINED WITHIN SPECIFICATINS WITH ALL LOTS OF REAGENT IN USE. THERE IS NO IMPACT TO PT MGMT 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 LSO ABBOTT LABORATORIES NA 31293M200

    Patients

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