BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HCV 3.0

    MDR report key: 1271144 · Received December 26, 2008

    Report

    Report Number
    1415939-2008-00533
    Event Type
    Malfunction
    Date Received
    December 26, 2008
    Report Date
    December 18, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONS: AXSYM HCV VERSION 3.0 LIST#: 3B44-20 , LOT#: 60368LF00, EXPIRES: 10-11-2008; LOT#: 62476LF00, EXPIRES: 12-11-2008; LOT#: 65104LF00, EXPIRES: 01-01-2009; LOT#: 66086LF00, EXPIRES: 02-082009; LOT#: 67470LF00, EXPIRES: 02-082009. NO RETURNS WERE RECEIVED FOR THIS INVESTIGATION FROM THE CUSTOMER SITE (NOTE: LOT NUMBERS 60368LF00, 62476LF00, AND 65104LF00 WERE ALREADY EXPIRED UPON RECEIPT OF THIS COMPLAINT. HISTORICAL TEST DATA FOR LOT 60368LF00 ONLY WAS AVAILABLE). THREE AXSYM HCV VERSION 3.0 REAGENT KITS (LIST NUMBER 3B44-20, LOT NUMBERS 67470LF00, 66086LF00 AND 60368LF00), STORED AT ABBOTT WERE TESTED FOR ANALYTICAL AND CLINICAL SENSITIVITY. CALIBRATION AND CONTROLS WERE WITHIN THE SPECIFICATION RANGE AS PER PACKAGE INSERT. ALSO, SENSITIVITY PANELS FOR CORE, C100, 33C AND NS5 EPITOPES WERE WITHIN THE SPECIFICATION RANGE. IN ADDITION, TWO ANTI-HCV SEROCONVERSION PANELS (BBI PHV 905 FOR LOT NUMBERS 67470LF00 AND 66086LF00 AND BBI PHV914 FOR LOT NUMBER 60368LF00) WERE TESTED WITH THE AXSYM HCV VERSION 3.0 REAGENT KITS IN QUESTION AND SHOWED THE EXPECTED NUMBER OF REACTIVE BLEEDS WITH S/CO VALUES COMPARABLE TO IN-HOUSE REFERENCE REAGENT LOTS. AS PART OF THE INVESTIGATION A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS FOR AXSYM HCV VERSION 3.0 REAGENT KITS, LIST NUMBER 3B44-20, LOT NUMBERS 60368LF00, 62476LF00, 65104LF00, 66086LF00, AND 67470LF00. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. IN THE ABBOTT AXSYM SYSTEM OPERATION MANUAL, SECTION 10, PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR PROBLEMS REGARDING ERRATIC RESULTS ARE LISTED; ALSO, THE AXSYM HCV VERSION 3.0 REAGENT KIT (LIST NUMBER 3B44-20) PACKAGE INSERT PROVIDES SAMPLE HANDLING PROCEDURES. THE COMPLAINT ISSUE REGARDING THE POTENTIAL FALSE NON-REACTIVE PATIENT RESULTS REMAINS UNCLEAR, PARTLY BECAUSE PATIENT SAMPLES AND REAGENT KITS WERE NOT AVAILABLE FOR THIS INVESTIGATION. BASED ON THE CURRENT INVESTIGATION, IT WAS DETERMINED THAT THE AXSYM HCV VERSION 3.0 REAGENT KITS, LIST NUMBER 3B44-20, LOT NUMBERS 60368LF00, 62476LF00, 65104LF00, 66086LF00, AND 67470LF00, IDENTIFIED IN THE CUSTOMER COMPLAINT ARE PERFORMING ACCEPTABLY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US. 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 STATES THAT A PATIENT SAMPLE GENERATED A NON-REACTIVE RESULT WITH THE AXSYM HCV V3.0 ASSAY. THE SAMPLE TESTED REACTIVE BY VARIOUS OTHER METHODOLOGIES. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER LN:7A83-01 SN:(B)(4)| AXSYM ANALYZER LN:7A83-01 SN:(B)(4)