BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM ANTI-HCV

    MDR report key: 1152784 · Received September 10, 2008

    Report

    Report Number
    1628664-2008-00156
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    P970027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME AXSYM ANTI-HCV 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 ANTI-HCV (CUSTOMER RESULT) = NONREACTIVE; ALTERNATE SCREENING ASSAY - ABBOTT HCV EIA 2.0 (CUSTOMER RESULT) = REACTIVE; RIBA (REFERENCE TESTING) = NEGATIVE; HCV NAT (REFERENCE TESTING) = NOT TESTED. THEREFORE, THE SPECIMEN CATEGORY IS INCONCLUSIVE, AS THERE WAS INSUFFICIENT VOLUME OF THE RETURNED SAMPLE TO PERFORM THE HCV NAT REFERENCE TESTING. HOWEVER, THE RIBA TESTING CONFIRMED THE RESULT OF THE AXSYM ANTI-HCV ASSAY. BASED ON THE INVESTIGATION CONDUCTED, THE AXSYM ANTI-HCV 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. THE AXSYM ANTI-HCV ASSAY IS USED FOR DIAGNOSTIC PURPOSES. PER THE CDC, ALL REACTIVE HCV SAMPLES SHOULD BE TESTED BY A CONFIRMATION METHOD. AS THE AXSYM ANTI-HCV ASSAY REQUIRES CAREFUL SAMPLE COLLECTION AND SAMPLE HANDLING, WHICH OTHERWISE MAY LEAD TO DISCREPANT RESULTS, THE CUSTOMER IS REFERRED TO THE ASSAY PACKAGE INSERT (COMMODITIES, 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 ANTI-HCV 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 AND ABBOTT EIA (PPC) PLATFORMS. ONE PT SAMPLE GENERATED AN AXSYM ANTI-HCV NON-REACTIVE RESULT WHILE THE SAMPLE GENERATED A REACTIVE RESULT WITH THE EIA METHODOLOGY. THIS PT IS A TRANSPLANT CANDIDATE. THERE WAS NO IMPACT TO PT MGMT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM ANTI-HCV IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT LABORATORIES NA 59676M100

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANTI-HCV ASSAY LIST# 5C36-20 LOT# 59676M100