BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM AUSAB

    MDR report key: 1152783 · Received September 10, 2008

    Report

    Report Number
    1628664-2008-00155
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    PMA / PMN Number
    P060003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT AXSYM SYSTEM MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME AXSYM REAGENT, MANUFACTURING SITE. PATIENT SAMPLES WERE RETURNED FROM THE CUSTOMER SITE. THE INVESTIGATION BEGAN WITH A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO DATE IN ORDER TO DETERMINE IF OTHER CUSTOMERS HAVE EXPERIENCED THIS SAME ISSUE. THE REVIEW OF THIS DATA DID NOT IDENTIFY AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO RESULTS NOT CORRELATING WITH THE PATIENT?S CLINICAL PICTURE WHILE USING THE ASSAY IN QUESTION. CHARACTERIZATION TESTING WAS THEN PERFORMED ON THE RETURNED SPECIMENS AND IT WAS DETERMINED THAT THE AXSYM ASSAY IS PERFORMING AS INTENDED: AXSYM US (CUSTOMER RESULT) = REACTIVE; ALTERNATE ANTI-HBS ASSAY - EIA (ABBOTT RESULT) = REACTIVE; TOTAL ANTI-HBC ASSAY - AXSYM CORE 2.0 (ABBOTT RESULT) = NONREACTIVE. THEREFORE, BASED ON THE TEST ALGORITHM, THE SPECIMEN CATEGORY IS NOT A FALSE POSITIVE. BASED ON THE INVESTIGATION CONDUCTED, THE AXSYM ASSAY IS PERFORMING AS INTENDED. ALTHOUGH WE CANNOT PROVIDE A SPECIFIC REASON FOR THE RESULTS OBSERVED AT THE CUSTOMER SITE, THIS PRODUCT WILL CONTINUE TO BE MONITORED FOR ISSUES AND APPROPRIATE ACTION WILL BE TAKEN AS NEEDED. BOTH THE AXSYM AND THE EIA ASSAYS WERE DESIGNED TO DETECT THE SAME SEROTYPES OF ANTI-HBS. WHILE THE EIA IS A QUALITATIVE ASSAY, THE RESULTS ARE BASED ON A DETECTION LIMIT, AND DO NOT PROVIDE AN ASSESSMENT OF THE LEVEL OF ANTI-HBS RELATIVE TO A PATIENT?S IMMUNE STATUS. AXSYM, AS A QUANTITATIVE ASSAY, PROVIDES A RESULT THAT COULD BE USED TO ASSESS THE LEVEL OF ANTI-HBS RELATIVE TO A PATIENT?S IMMUNE STATUS. AS THE AXSYM ASSAY REQUIRES CAREFUL SAMPLE COLLECTION AND SAMPLE HANDLING, WHICH OTHERWISE MAY LEAD TO DISCREPANT RESULTS, THE CUSTOMER IS REFERRED TO THE ASSAY PACKAGE INSERT FOR THE VARIOUS CONDITIONS THAT MIGHT CONTRIBUTE TO DISCREPANT ASSAY VALUES (ESPECIALLY THE SECTION ENTITLED: SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS). BASED ON THE RESULTS OF THIS INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED, THE QUALITY DATA REVIEW MET ACCEPTANCE CRITERIA, AND TESTING WITH THE PATIENT SAMPLE INDICATED THAT THE CUSTOMER OBSERVED ISSUE WAS SPECIFIC TO THE SAMPLE. THE AXSYM ASSAY IS PERFORMING AS INTENDED. NO ADDITIONAL ISSUES WERE FOUND DURING THIS INVESTIGATION, SO FURTHER INVESTIGATION IS NOT REQUIRED. THIS IS A FINAL REPORT.

    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 IS PERFORMING A CORRELATION STUDY BETWEEN THE ABBOTT AXSYM ANALYZER AND THE ABBOTT EIA (PPC) PLATFORMS. ONE PT SAMPE GENERATED AN AXSYM AUSAB ASSAY RESULT OF REACTIVE WHILE THE SAME SAMPLE GENERATED A NON-REACTIVE RESULT WITH THE EIA METHODOLOGY. NO OTHER TESTING HAS BEEN PERFORMED. THIS PT IS ON DIALYSIS AND IS A KIDNEY TRANSPLANT CANDIDATE. THERE IS NO IMPACT TO PT MGMT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM AUSAB FOR THE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN LOM ABBOTT LABORATORIES NA 59002M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM AUSAB REAGENT LIST# 3C74-20 LOT#59002M100