BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 3043079 · Received April 9, 2013

    Report

    Report Number
    3002809144-2013-00101
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    PMA / PMN Number
    P050042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 01L79.

    Additional Manufacturer Narrative · 1

    CATALOG # CHANGED FROM 06C37-30 TO 06C37-20; LOT# CHANGED FROM UNKNOWN TO 22780LI00. A REVIEW OF COMPLAINT RECORDS FOR LOT NUMBER 22780LI00 DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE COMPLAINT OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE COMPLAINT ISSUE IS SUFFICIENTLY ADDRESSED. A RETAINED REAGENT KIT OF ARCHITECT ANTI-HCV REAGENT, LIST NUMBER 6C37-20, LOT NUMBER 22780LI00 WAS CALIBRATED AND ALL CONTROL VALUES MET SPECIFICATIONS. ANALYTICAL SENSITIVITY WAS EVALUATED WITH TESTING OF TEN REPLICATES OF TWO SENSITIVITY PANELS (CORE ONLY PANEL AND NS3 ONLY PANEL). THE MEAN S/CO OF THE SENSITIVITY PANEL VALUES MET SPECIFICATIONS AND ALL GENERATED RESULTS WERE IN THE TYPICAL RANGE. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HCV SEROCONVERSION PANELS HCV 9041 AND HCV 9045). THE PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX AND THEY DETECTED THE SAME BLEEDS AS (B)(4) WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANELS, THUS SHOWING THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. A REVIEW OF MANUFACTURING AND TESTING RECORDS FOR LOT 22780LI00 DID NOT REVEAL ANY EVENTS OR ISSUES THAT MAY HAVE IMPACTED THE PERFORMANCE IN RELATION TO THE COMPLAINT ISSUE. BASED ON OUR INVESTIGATION, WE HAVE DETERMINED THAT LOT 22780LI00 IS CURRENTLY MEETING ITS SAFETY, EFFECTIVENESS, AND LABEL CLAIMS. DUE TO DIFFERENCES IN ASSAY FORMATS AND TECHNOLOGIES, SPECIMENS THAT ARE NOT DETECTED BY ONE ASSAY MAY BE DETECTED BY ANOTHER. AS WITH ALL IMMUNOASSAYS, (B)(4) RESULTS CANNOT BE EXCLUDED COMPLETELY. THE SENSITIVITY SPECIFICATION OUTLINED IN THE PACKAGE INSERT INDICATES THAT SUCH CASES OCCUR VERY INFREQUENTLY. A (B)(4)RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO (B)(4), SINCE CURRENT METHODS FOR THE DETECTION OF ANTIBODIES TO (B)(4) MAY NOT DETECT ALL INFECTED INDIVIDUALS. IF THE ARCHITECT ANTI-HCV RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT ANALYZER GENERATED A (B)(6) RESULT ON A PATIENT (SID (B)(4)). SPECIMENS WITH RESULTS LESS THAN 1.00 S/CO ARE CONSIDERED NONREACTIVE. RESULTS PROVIDED: INITIAL RESULT RAN ON THE ARCHITECT ON (B)(6) 2013 = (B)(6). PCR RESULT AT RT FOR (B)(6) WAS ALSO (B)(6). THE PATIENT SAMPLE WAS TESTED FOR (B)(6) BY THE ROCHE COBAS 6000 AND GENERATED A (B)(6) RESULT ((B)(6)). (B)(6) IMMUNOBLOT TEST WAS PERFORMED AND GENERATED A (B)(6) RESULT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145493 ARCHITECT ANTI-HCV MZO ABBOTT GERMANY 22780LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR SERIAL NUMBER (B)(4)| ARCHITECT I1000SR ANALYZER, LIST # 01L86-01| ARCHITECT I1000SR ANALYZER, LIST # 01L86-01| SERIAL NUMBER (B)(4)