BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM PLUS ANALYZER

    MDR report key: 2102546 · Received May 25, 2011

    Report

    Report Number
    1415939-2011-00162
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    P060003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE ISSUE OF DISCREPANT AXYM AUSAB RESULTS OCCURRED WHEN THE CUSTOMER USED A NEW PACK OF AXSYM AUSAB REAGENT. NO DISCREPANT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER THEN USED A NEW AUSAB REAGENT PACK, AND PERFORMED TROUBLESHOOTING PROCEDURES, WHICH INCLUDED FLUSHING THE AXSYM PROBES. NO ADDITIONAL DISCREPANT CONTROL OR PATIENT RESULTS WERE GENERATED BY THE AXSYM PLUS ANALYZER AFTER THIS PROCEDURE WAS COMPLETED. THE AXSYM SYSTEM OPERATION MANUAL (LIST NO. 09A26-06) AND THE AXSYM AUSAB ASSAY PACKAGE INSERT (66-6609/R1) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION AND THE CURRENT EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE AXSYM PLUS ANALYZER LIST NO. 07A83-03 RELATED TO THE ISSUE UNDER EVALUATION. EVALUATION , METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING. THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME AXSYM AUSAB, ABBOTT LABORATORIES, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME AXSYM PLUS ANALYZER, (B)(4) MANUFACTURING SITE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A (B)(6) RESULT WAS GENERATED BY THE AXSYM AUSAB ASSAY. THE CUSTOMER STATES THAT AXSYM AUSAB (NEW) LOT 96284M500 IS EXHIBITING A (B)(6) BIAS/IMPRECISION FOR BOTH CONTROL AND PATIENT SAMPLES WHEN COMPARED TO THE FORMER LOT IN USE. THE CUSTOMER GAVE THE FOLLOWING EXAMPLES: (B)(6). THE CTA RECOMMENDED A NUMBER OF TROUBLESHOOTING PROCEDURES TO TRY AND IS SENDING THE CUSTOMER A NEW REAGENT KIT OF THE SAME LOT. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM PLUS ANALYZER FOR THE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN JJE ABBOTT MANUFACTURING INC 96284M500

    Patients

    Seq Age Sex Outcome Treatment
    1 AX AUSAB LN:3C74-20 LOT:96284M500| AX AUSAB LN:3C74-20 LOT:96284M500| AXSYM PLUS LN: 7A83-03 SN: (B)(4)