BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1771451 · Received July 27, 2010

    Report

    Report Number
    1628664-2010-00273
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). TO INVESTIGATE THE CUSTOMER ISSUE AN INVESTIGATION WAS CONDUCTED WHICH INCLUDED A REVIEW OF THE COMPLAINT TEXT, THE INSTRUMENT HISTORY AND THE AXSYM SYSTEM LABELING. AN EXACT CAUSE OF THE CUSTOMER ISSUE COULD NOT BE IDENTIFIED WITH THE AVAILABLE INFORMATION. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS PROBABLE CAUSES AND CORRECTIONS FOR ERRATIC RESULTS. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TRENDS ASSOCIATED WITH THIS ISSUE. A SERVICE HISTORY REVIEW OF AXSYM SERIAL NUMBER (B)(4) FROM (B)(6) 2010 INDICATES THERE WERE NO OTHER COMPLAINTS GENERATED RELATED TO THIS ISSUE. BASED UPON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE AXSYM ANALYZER, LIST NUMBER 7A83-27, SERIAL NUMBER (B)(4), IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE AXSYM ANALYZER GENERATED A FALSE POSITIVE AXSYM CMV IGM RESULT OF 0.67 INDEX. THE SAMPLE WAS REPEATED ON THE AXSYM, GENERATING THE SAME RESULT. THE SAMPLE WAS THEN RUN ON THE ARCHITECT I2000SR, OBTAINING A NEGATIVE RESULT OF 0.49 INDEX. A FRESH SAMPLE COLLECTED AND RUN ON THE AXSYM GENERATED A POSITIVE AXSYM CMV IGM RESULT OF 0.806 INDEX. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM CMV IGM| AXSYM CMV IGM