BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1591762 · Received February 2, 2010

    Report

    Report Number
    1628664-2010-00060
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    January 3, 2010
    Report Date
    January 7, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LOM
    PMA / PMN Number
    K950915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THROUGH TROUBLESHOOTING BY THE ABBOTT CUSTOMER TECHNICAL ADVOCATE, IT WAS DISCOVERED THAT MAINTENANCE WAS NOT PERFORMED AND CONTROLS WERE NOT RUN ON THE AXSYM ANALYZER PRIOR TO TESTING ON (B) (6) 2010. THE NEXT DAY, CONTROLS WERE OUT OF RANGE HIGH. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE PROVIDED TRAINING TO THE CUSTOMER TO PERFORM AXSYM MAINTENANCE PROCEDURES. THE CUSTOMER WAS ALSO REFERRED TO THE AXSYM HBSAG PACKAGE INSERT WHICH STATES INITIAL REACTIVE SAMPLE RESULTS SHOULD BE RETESTED IN DUPLICATE AND A NEUTRALIZING CONFIRMATORY TEST SHOULD BE PERFORMED ON REPEATEDLY REACTIVE SAMPLES. QUALITY CONTROL PROCEDURES WERE ALSO REVIEWED WITH THE CUSTOMER TO PERFORM THE POSITIVE AND NEGATIVE CONTROLS AS INDICATED IN THE ASSAY PACKAGE INSERT. COMPLAINT TRACKING AND TRENDING WAS REVIEWED WITH NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE FOR THE ERRATIC RESULTS WAS FAILURE OF THE OPERATOR TO PERFORM MAINTENANCE PROCEDURES AND FOLLOW ASSAY PACKAGE INSERT INSTRUCTIONS FOR QUALITY CONTROL AND INTERPRETATION OF RESULTS. A DEFICIENCY OF THE AXSYM SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED A NEWBORN INFANT RECEIVED HBIG DUE TO A FALSE INITIAL REACTIVE AXSYM HBSAG RESULT. ON (B) (6) 2010, THE NEWBORN INFANT TESTED AXSYM HBSAG INITIAL REACTIVE AND NO REPEAT OR CONFIRMATORY TESTING WAS PERFORMED. THE AXSYM HBSAG RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE NEWBORN INFANT RECEIVED HBIG. THERE WAS NO ADDITIONAL IMPACT TO THE NEWBORN INFANT AFTER RECEIPT OF HBIG. ON (B) (6) 2010, A NEW SPECIMEN WAS OBTAINED FROM THE NEWBORN INFANT WHICH TESTED AXSYM HBSAG NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER LOM ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AXSYM HBSAG LIST 7A40-88, LOT UNKNOWN