BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HCV 3.0

    MDR report key: 1408491 · Received July 1, 2009

    Report

    Report Number
    1415939-2009-01066
    Event Type
    Malfunction
    Date Received
    July 1, 2009
    Date of Event
    June 18, 2009
    Report Date
    June 18, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: - DEVICE NOT RETURNED. CUSTOMER RETURNED SAMPLES EVALUATED AND CUSTOMER RESULTS DUPLICATED. REFERENCE TESTING OF SAMPLES INDICATED NO EVIDENCE FOR ANTI-HCV. RETAINED KIT TESTING MET ALL SPECIFICATIONS. THE CUSTOMER RETURNED SAMPLES WERE TESTED AND THE RESULTS ARE AS FOLLOWS: THE SAMPLES WERE TESTED (B)(6) USING AN IN-HOUSE KIT OF AXSYM HCV VERSION 3.0, LOT NUMBER 74152LF00. THE SAMPLE (B)(6) WAS TESTED WITH A VALUE OF (B)(6) AND (B)(6) WITH A VALUE OF (B)(6). BOTH SAMPLES WERE ADDITIONALLY TESTED (B)(6) ON PRISM HCV (LN 6A52) (REFER TO COMPLAINT INVESTIGATION (B)(4)) AND CHIRON RIBA HCV 3.0 SIA IMMUNOBLOT. BASED ON THE RESULTS OBTAINED BY AXSYM ABBOTT HCV VER. 3.0, PRISM HCV AND CHIRON RIBA HCV 3.0 SIA, WE CONCLUDE (B)(6). BOTH SAMPLES ARE THEREFORE CONSIDERED NOT FALSE (B)(6) FOR ANTI-HCV. SUPPLEMENTARY TESTING WAS PERFORMED USING ARCHITECT HCV AG (REFER TO COMPLAINT INVESTIGATION (B)(4)). THIS ASSAY DETERMINES THE CONCENTRATION OF HEPATITIS C VIRUS CORE ANTIGEN IN THE SPECIMENS. THE SAMPLE (B)(6) WAS TESTED WITH A VALUE OF (B)(6) FOR HCV AG AND (B)(6) WITH A VALUE OF (B)(6) FOR HCV AG. IN CONSIDERATION OF THE DISCREPANT IMMUNOASSAY RESULTS FOR ANTIBODIES SAMPLE (B)(6) MAY BE (B)(6). THE INVESTIGATION TEAM PERFORMED ADDITIONAL TESTING OF LOT 74152LF00 TO RE-EVALUATE THE ANALYTICAL AND CLINICAL SENSITIVITY: LOT NUMBER 74152LF00 SHOWED A PERFORMANCE WITHIN TYPICAL RANGES AND WITHIN CUSTOMER SPECIFICATIONS FOR CALIBRATORS, CONTROLS AND SENSITIVITY PANELS FOR ANTIBODIES DIRECTED AGAINST CORE, C100, 33C AND NS5-ANTIGEN. TESTING OF TWO COMMERCIAL ANTI-HCV SEROCONVERSION PANELS (BBI PHV905 AND PHV914) WITH LOT NUMBER 74152LF00 SHOWED THE EXPECTED NUMBER OF REACTIVE BLEEDS WITH S/CO VALUES FOR THE SEROCONVERSION PANELS PHV905 AND PHV914 COMPARABLE TO INTERNAL HISTORICAL DATA. AS PART OF OUR INVESTIGATION, WE HAVE REVIEWED THE COMPLAINT AND MANUFACTURING RECORDS FOR LOT NUMBER 74152LF00. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER OBSERVATION. BASED ON THIS INVESTIGATION, IT IS DETERMINED THAT AXSYM HCV VERSION 3.0 REAGENT KIT, LIST NUMBER 3B44-20, LOT NUMBER 74152LF00, IDENTIFIED IN THIS COMPLAINT, IS PERFORMING ACCEPTABLY WITH REGARDS TO ANALYTICAL AND CLINICAL SENSITIVITY. IT IS RECOGNIZED THAT (B)(6). THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, AXSYM HCV V3.0, LIST 3B44, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, AXSYM ANTI-HCV, LIST 5C36. THE EVENT WAS ALSO SUBMITTED AS AN MDR FOR PRISM HCV, LIST 6A52; REFER TO 141539-2009-01047 AND 141539-2009-01048.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 ACCOUNT GENERATED FALSE NEGATIVE AXSYM HCV V3.0 RESULTS ON TWO DONOR SPECIMENS WHICH TESTED NAT POSITIVE. IN 2009, TWO DONORS TESTED PRISM HCV NEGATIVE. THE RBC PRODUCTS FOR BOTH DONORS WERE DELIVERED TO TWO RECIPIENTS. THE PLASMA PRODUCTS FOR BOTH DONORS WERE SENT TO A LOCAL MANUFACTURE COMPANY. THE LOCAL MANUFACTURE COMPANY PERFORMED POOLED NAT TESTING WHICH IDENTIFIED TWO DIFFERENT DONORS AS POSITIVE. THE ACCOUNT RETESTED THE 2 DONOR SPECIMENS AGAIN AT ABOUT ONE MONTH LATER, WHICH TESTED PRISM HCV NEGATIVE, AXSYM HCV V3.0 NEGATIVE AND BIO-RAD MONOLISA AG-AB POSITIVE FOR ONE DONOR SPECIMEN BUT NEGATIVE FOR THE OTHER DONOR SPECIMEN. THE PLASMA FOR BOTH DONORS WERE RETURNED FROM THE LOCAL MANUFACTURE COMPANY. NO INFORMATION WAS PROVIDED REGARDING THE TWO DONORS OR TWO RECIPIENTS. THIS REPORT IS FOR DONOR 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM HCV 3.0 IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT LABORATORIES 74152LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER LIST 7A83-86, SERIAL (B)(4)| AXSYM ANALYZER LIST 7A83-86, SERIAL (B)(4)