BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HCV 3.0

    MDR report key: 1281683 · Received January 9, 2009

    Report

    Report Number
    1415939-2009-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 9, 2008
    Report Date
    December 16, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, NO METHOD, RESULTS OR CONCLUSION CODE CAN BE CHOSEN AT THIS TIME. 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. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    OTHER CODE: DEVICE AND SAMPLES NOT RETURNED; RESERVE SAMPLES MET SPECIFICATIONS. NO RETURNS WERE RECEIVED FOR THIS INVESTIGATION. THE INVESTIGATION TEAM HAVE COMPLETED AN INVESTIGATION AND THE RESULTS ARE AS FOLLOWS: FOUR AXSYM HCV VERSION 3.0 REAGENT KITS, LIST NUMBER 3B44-20, LOT NUMBERS 67470LF00, 66086LF00, 67541LF00 AND 69396LF00, STORED AT ABBOTT WERE TESTED FOR ANALYTICAL AND CLINICAL SENSITIVITY. THE CHOICE OF THESE LOT NUMBERS WAS BASED ON THE DELIVERY DATES TO THE ACCOUNT LABORATORY IN THE RELEVANT TIME FRAME. THE 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, AN ANTI-HCV SEROCONVERSION PANEL (BBI PHV 905) WAS TESTED WITH ABOVE MENTIONED REAGENT KITS AND SHOWED THE EXPECTED NUMBER OF REACTIVE BLEEDS WITH S/CO VALUES COMPARABLE TO TWO REFERENCE REAGENT LOTS.AS PART OF THIS INVESTIGATION THE INVESTIGATION TEAM HAVE REVIEWED THE COMPLAINT AND MANUFACTURING RECORDS FOR AXSYM HCV VERSION 3.0 REAGENT KITS, LIST NUMBER 3B44-20, LOT NUMBERS 67470LF00, 66086LF00, 67541LF00 AND 69396LF00. THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE ACCOUNT OBSERVATION.BASED ON THIS INVESTIGATION, IT IS DETERMINED THAT AXSYM HCV VERSION 3.0 REAGENT KITS, LIST NUMBER 3B44-20, LOT NUMBERS 67470LF00, 66086LF00, 67541LF00 AND 69396LF00, POTENTIALLY INVOLVED IN THIS COMPLAINT, ARE PERFORMING ACCEPTABLY. THE INVESTIGATION TEAM DOES NOT KNOW THE SPECIFIC REASON THIS OCCURRED. PLEASE ENSURE THAT SUFFICIENT VOLUME IS PRESENT IN THE SAMPLE CUPS OR TUBES FOR PATIENT SAMPLE TESTING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE NEGATIVE AXSYM HCV V3.0 RESULT ON A PATIENT SPECIMEN. IN 2008, THE SPECIMEN TESTED AXSYM HCV V3.0 NEGATIVE (0.32 S/C) ON A PATIENT WHO HAD A MEDICAL HISTORY OF TESTING HCV POSITIVE. A NEW SPECIMEN WAS OBTAINED WHICH TESTED AXSYM HCV V3.0 REACTIVE (60.5 S/CO). NO FURTHER DATA IS AVAILABLE. IT IS UNCLEAR IF THE NEGATIVE AXSYM HCV V3.0 RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS 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 MZO ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM LIST 7A83-03| AXSYM LIST 7A83-03