BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM CMV IGM

    MDR report key: 1646488 · Received March 31, 2010

    Report

    Report Number
    1415939-2010-00289
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LKQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT HAS GENERATED FALSE POSITIVE AXSYM CMV IGM ASSAY INDEX RESULTS OF 1.022 AND 1.212. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CMV IGM FOR THE MEASUREMENT OF IGM ANTIBODIES TO CYTOMEGALOVIRUS LKQ ABBOTT LABORATORIES 81282M100

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM PLUS REFURB ANALYZER LN: 7A83-82 (B)(4)| AXSYM PLUS REFURB ANALYZER LN: 7A83-82 (B)(4)