BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG ANTIBODY

    MDR report key: 1061573 · Received June 17, 2008

    Report

    Report Number
    1415939-2008-00086
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    April 14, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Removal / Correction Number
    1415939-6/06/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE CUSTOMER CONTACTED ABBOTT TO REPORT THE INABILITY TO CALIBRATE A NEW LOT OF REAGENT FOR THE AXSYM RUBELLA IGG ASSAY AND OBSERVED ERROR CODE 1018 (CALIBRATOR A CHECK FAILURE). THE CUSTOMER STATED THEY WERE TROUBLESHOOTING AN OPTICS ISSUE AND WOULD WAIT UNTIL THE OPTICS ISSUE WAS RESOLVED BEFORE ATTEMPTING TO RESOLVE THE RUBELLA CALIBRATION ISSUE. ABBOTT FIELD SERVICE WAS SENT TO THE CUSTOMER FACILITY AND THE CUSTOMER REPORTED THE CALIBRATION ISSUE PERSISTED AFTER SERVICE. THE CUSTOMER WAS SENT A NEW LOT OF REAGENT AND UPON RECALIBRATION, STATED THE RUBELLA CALIBRATION ISSUE WAS UNSUCCESSFUL. ADDITIONALLY, THE CUSTOMER REPORTED THERE IS NO CALIBRATION ISSUE WITH OTHER AXSYM ASSAYS. ABBOTT REQUESTED THE CALIBRATION DATA FOR EVALUATION BY ABBOTT, AND SENT THE CUSTOMER A NEW LOT OF CALIBRATORS FOR TROUBLESHOOTING WHICH DID NOT RESOLVE THE ISSUE. THE CUSTOMER RETURNED THE REAGENTS AND CALIBRATORS FOR INVESTIGATION. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGG ANTIBODY MEIA FOR THE MEASUREMENT OF IGM ANTIBODIES TO RUBELLA VIRUS LFX ABBOTT LABORATORIES NA 60943M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT# 58184M100| LOT# 61236M200| AXSYM RUBELLA CALIBRATORS:| AXSYM RUBELLA CALIBRATORS| AXSYM ANALYZER