BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV REAGENT

    MDR report key: 1374598 · Received May 6, 2009

    Report

    Report Number
    2623532-2009-00032
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US. THE CUSTOMER RETURNED PATIENT SPECIMEN WAS RECEIVED AND TESTED. TESTING PERFORMED USING A RETAINED SAMPLE (REAGENT KIT STORED AT ABBOTT LABORATORIES) OF LIST NUMBER (RELABELED IN OTHER COUNTRY), LOT NUMBER 55044HN00 SHOWED THAT THE NEGATIVE CONTROL AND POSITIVE CONTROL WERE WITHIN THE SPECIFICATION RANGES. THE CUSTOMER RETURNED PATIENT SPECIMEN WAS TESTED IN THREE REPLICATES. THE SPECIMEN WAS TESTED NON-REACTIVE WITH VALUES NEAR THE ASSAY CUT-OFF OF 0.83, 0.82 AND 0.75 S/CO. THUS WE COULD REPEAT THE NON-REACTIVE RESULTS THE CUSTOMER OBSERVED. IN ADDITION, TESTING OF THE SPECIMEN WAS THEN PERFORMED USING CHIRON RIBA HCV 3.0 SIA AND OBTAINED AN INDETERMINATE RESULT ACCORDING TO THE RESPECTIVE PACKAGE INSERT SHOWING A FAINT BAND FOR C33C (=NS3) AND A WEAK BAND FOR C22 (=CORE). FINALLY, A SECOND IMMUNOBLOT TEST (INNOGENETICS INNO-LIA HCV) WAS PERFORMED AND OBTAINED AGAIN AN INDETERMINATE RESULT FOR THE CUSTOMER RETURNED SPECIMEN WITH ONLY A SINGLE WEAK BAND FOR NS3. THIS TWO INDETERMINATE IMMUNOBLOT RESULTS FIT WELL TO THE OBTAINED ELEVATED, BUT STILL NEGATIVE S/CO VALUES OF THE ARCHITECT RESULTS. NEVERTHELESS, ON THE BASIS OF THESE TEST RESULTS (OBTAINED AT THE CUSTOMER SITE AND DURING THIS INVESTIGATION) THE PATIENT SPECIMEN MUST BE CLASSIFIED AS 'FALSE NON-REACTIVE' FOR ARCHITECT ANTI-HCV, LOT NUMBER 55044HN00 DUE TO TWO INDETERMINATE RESULTS ON THE IMMUNOBLOTS GENERATED DURING INVESTIGATION AND THE REACTIVE RESULT ON AXSYM GENERATED AT THE CUSTOMER SITE. THE ANALYTICAL AND CLINICAL SENSITIVITY OF ARCHITECT ANTI-HCV, LOT NUMBER 55044HN00 WAS INVESTIGATED BY TESTING SENSITIVITY PANEL A (CORE ONLY), SENSITIVITY PANEL B (NS3 ONLY) AND TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. THE RESULTS FOR SENSITIVITY PANEL A AND SENSITIVITY PANEL B WERE IN ACCEPTABLE PERFORMANCE RANGE. FOR THE TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS THE SAME BLEEDS WERE FOUND REACTIVE COMPARED TO HISTORICAL DATA. THEREFORE, THERE IS NO INDICATION THAT THE ANALYTICAL OR CLINICAL SENSITIVITY OF THE ARCHITECT ANTI-HCV LOT 55044HN00 IS COMPROMISED. AS PART OF THIS INVESTIGATION A REVIEW WAS PERFORMED OF THE COMPLAINT AND MANUFACTURING RECORDS FOR ARCHITECT ANTI-HCV, LOT NUMBER 55044HN00. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER OBSERVATION. BASED ON THIS INVESTIGATION, IT IS DETERMINED THAT ARCHITECT ANTI-HCV REAGENT, LOT NUMBER 55044HN00 IDENTIFIED IN THE CUSTOMER COMPLAINT IS CURRENTLY MEETING ITS SAFETY, EFFECTIVENESS AND LABEL CLAIMS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING FOR AN INTERNATIONAL PRODUCT WITH A SIMILAR US PRODUCT. THE ACCOUNT STATED THAT ARCHITECT ANTI-HCV GENERATED A NONREACTIVE (S/CO 0.79) RESULT ON A PATIENT WHO HAS A HCV INFECTION. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND TESTED AXSYM ANTI-HCV REACTIVE (S/CO 1.70). THE PATIENT PREVIOUSLY TESTED AXSYM HCV REACTIVE (S/CO 1.50) AND PCR NEGATIVE IN 2003. THE NONREACTIVE ARCHITECT ANTI-HCV RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HCV REAGENT FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT DIAGNOSTICS INT'L, LTD 55044HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER