BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HCV 3.0

    MDR report key: 1381789 · Received May 15, 2009

    Report

    Report Number
    1415939-2009-00958
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    July 31, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ

    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. ONE KIT OF AXSYM HCV VERSION 3.0 LOT NUMBER 63327LF01 AND ONE ALIQUOT OF THE ACCURUN CONTROL WERE RECEIVED FOR INVESTIGATION. THREE REPLICATES OF THE ACCURUN 1 SERIES 2600 POSITIVE CONTROL WERE TESTED WITH THE CUSTOMER RETURNED REAGENT KIT LOT NUMBER 63327LF01 GIVING REACTIVE RESULTS OF 2.93, 2.97 AND 2.93 S/CO. THE ACCURUN 1 SERIES 2600 POSITIVE CONTROL WAS ALSO TESTED ON A KIT OF LOT NUMBER 63328LF00 (WHICH IS IDENTICAL TO LOT NUMBER 63327LF01 EXCEPT FOR THE LOT OF SPECIMEN DILUENT 1) STORED AT ABBOTT LABORATORIES. THE RESULTS WERE ALSO REACTIVE WITH VALUES OF 2.59, 2.65 AND 2.41 S/CO. THEREFORE, THE CUSTOMER'S OBSERVATION OF FALSE NON-REACTIVE ACCURUN 1 SERIES 2600 POSITIVE CONTROL COULD NOT BE REPEATED. IN ORDER TO VERIFY THE ANALYTICAL AND CLINICAL SENSITIVITY OF LOT NUMBER 63327LF00, SENSITIVITY AND SEROCONVERSION PANELS ON AN IN-HOUSE SAMPLE OF THIS LOT WERE TESTED. UNFORTUNATELY, NO VOLUME WAS REMAINING IN THE CUSTOMER RETURNED REAGENT KIT, SO IT COULD NOT BE TESTED. CALIBRATION, CONTROLS AND ALL SENSITIVITY PANELS (CORE, C100, 33C AND NS5 TESTED FOR FINAL LOT RELEASE) WERE WITHIN SPECIFICATIONS. IN ADDITION, TWO ANTI-HCV SEROCONVERSION PANELS (BBI PHV 905 AND 911) SHOWED THE EXPECTED NUMBER OF REACTIVE BLEEDS WITH S/CO VALUES COMPARABLE TO REFERENCE REAGENT LOTS (COMPARED TO HISTORICAL RESULTS OF REFERENCE REAGENT LOTS FROM DECEMBER 2003 AND OCTOBER 2007 RESPECTIVELY). AS PART OF THE INVESTIGATION, THE COMPLAINT AND MANUFACTURING RECORDS FOR LOT NUMBER 63327LF00 WERE REVIEWED. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. NO OTHER CUSTOMER HAS REPORTED A SIMILAR ISSUE WITH THIS LOT. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT AXSYM HCV VERSION 3.0 REAGENT KIT, LOT NUMBER 63327LF01 IS PERFORMING ACCEPTABLY WITH RESPECT TO SENSITIVITY CLAIMS. AN INVESTIGATION WAS PERFORMED FOR AXSYM ANALYZER. FIELD SERVICE REPLACED THE POWER I/O BOARD AS A PRECAUTION, REMOVED ALL OF THE BOARDS FROM THE CARD CAGE AND CLEANED THE CARD CAGE AND BOARDS AND REASSEMBLED THE ASSEMBLY. CONTROLS AND ASSAY RUNS WERE THEN AS EXPECTED. BACKUP DISK FILES ATTACHED TO THE COMPLAINT TEXT WERE REVIEWED AND IDENTIFIED THAT MULTIPLE CALIBRATION / MAINTENANCE PROCEDURES INCLUDING PROBE CALIBRATIONS, WERE PERFORMED AND TEMPERATURE ERRORS OCCURRED DURING THE TIME PERIOD OF THE CUSTOMER DESCRIBED ISSUE. THERE IS NO INDICATION THE INSTRUMENT GENERATED ERRATIC RESULTS. REVIEW OF SERVICE HISTORY OF AXSYM INDICATES THERE WERE NO ADDITIONAL DISCREPANT RESULT COMPLAINTS GENERATED FOLLOWING FIELD SERVICE INTERVENTION. A REVIEW OF METRICS IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER INVESTIGATION. THE ACTUAL ROOT CAUSE OF THE CUSTOMER ISSUE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND THE MULTIPLE CORRECTIVE ACTIONS PERFORMED. THE I/O BOARD WAS REPLACED AS A PRECAUTION AND THE CARD CAGE AND BOARDS WERE CLEANED. THERE HAVE BEEN NO FURTHER RESULT ISSUES DOCUMENTED FOLLOWING FIELD SERVICE INTERVENTION. ADDITIONALLY, CALIBRATION AND MAINTENANCE PROCEDURES INCLUDING PROBE CALIBRATIONS, WERE PERFORMED DURING THE TIME PERIOD OF THE CUSTOMER DESCRIBED ISSUE. A DEFICIENCY OF THE AXSYM SYSTEM WAS NOT IDENTIFIED. 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 CUSTOMER STATED THAT POSITIVE QUALITY CONTROL MATERIAL (IQS, ACCURUN) TESTED FALSELY NEGATIVE 0.68 S/CO) USING THE AXSYM HCV V3.0 ASSAY. THE IQS QUALITY CONTROL MATERIAL WAS RETESTED FIVE TIMES AND THE CORRECT RESULTS WERE GENERATED. THE CUSTOMER REPORTED THE INCIDENT. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

    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 63327LF01

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM