BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061635 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00067
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-6/6/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ABBOTT HAS DETERMINED THAT CALIBRATION FAILURES DUE TO ELEVATED CALIBRATOR A OR MASTER CALIBRATOR 1 RATES MAY OCCUR WHEN ATTEMPTING TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY. THIS ISSUE AFFECTS ALL LOTS OF AXSYM RUBELLA IGG, LIST NUMBER 3B23-20. THE CAUSE OF THIS ISSUE IS THE MATERIAL USED TO MFR THE CALIBRATOR A, MASTER CALIBRATOR 1 AND THE NEGATIVE CONTROL. WITH THIS ISSUE, THERE HAVE BEEN AN INCREASE IN COMPLAINTS FOR AXSYM RUBELLA IGG FOR ERROR CODES: 1018 (CALIBRATOR A RATES TOO HIGH), 1111 (MASTER CALIBRATOR 1 TOO HIGH), AND 1048 (A/B RATIO TOO HIGH). THERE IS NO IMPACT TO PT RESULTS OTHER THAN A POTENTIAL DELAY IN REPORTING RESULTS DUE TO INABILITY TO GENERATE A VALID CALIBRATION CURVE. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED RELATED TO THIS ISSUE. A PRODUCT CORRECTION HAS BEEN ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGG ANTIBODY MEIA FOR THE MEASUREMENT OF IGG ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 61151M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI 60943M100 (EXP. 9/22/2008)| RUBELLA IGG CONTROLS| 58294M100 (EXP. 9/1/2008)| AXSYM RUBELLA IGG MASTER CALIBRATORS| 57577M201 (EXP. 8/10/2008)| AXSYM ANALYZER| AXSYM RUBELLA IGG REAGENTS| 60943M101 (EXP. 9/22/2008)| 58296M101 (EXP. 10/05/2008)| 58296M100 (EXP. 10/05/2008)| 58295M101 (EXP. 9/22/2008)| 55921M101 (EXP. 6/9/2008)| 56659M200 (EXP. 7/21/2008)| 56659M201 (EXP. 7/21/2008)| 57577M200 (EXP. 8/10/2008)| 58294M101 (EXP. 9/1/2008)| LIST NUMBER 9C29-01| 55921M100 (EXP. 6/9/2008)| 58295M100 (EXP. 9/22/2008)| 55922M100 (EXP. 6/20/2008)| 55922M101 (EXP. 6/20/2008)| 56323M100 (EXP. 6/30/2008)| LIST NUMBER 9C29-10| 56323M101 (EXP. 6/30/2008)| LIST NUMBER 3B23-20