BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXSYM CORE

    MDR report key: 2471553 · Received February 28, 2012

    Report

    Report Number
    1415939-2012-00054
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 1, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) RESULT. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7A41, AXSYM CORE , THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8B88, AXSYM CORE 2.0. ONE RETAINED KIT EACH OF AXSYM (B)(6) REAGENT PACK, LIST NUMBER 7A40-22, LOT NUMBER 08233LF00 AND OF AXSYM CORE REAGENT PACK, LIST NUMBER 7A41-20, LOT NUMBER 09228LF00 WAS CALIBRATED AND THE CALIBRATION MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TO EVALUATE REAGENT SPECIFICITY, SPECIFICITY PANELS WERE TESTED FOR EACH ASSAY. SPECIFICITY PANEL VALUES MET SPECIFICATIONS AND THE RESULTS WERE IN THE TYPICAL RANGE FOR BOTH ASSAYS AND NO FALSE REACTIVE RESULTS WERE OBTAINED. ALL GENERATED DATA DEMONSTRATE THAT THE PERFORMANCE OF THE AXSYM (B)(6) REAGENT PACK, LIST NUMBER 7A40-22, LOT NUMBER 08233LF00, AXSYM CORE REAGENT PACK, LIST NUMBER 7A41-20, LOT NUMBER 09228LF00 ARE NOT COMPROMISED. AS PART OF OUR EVALUATION, WE HAVE REVIEWED THE COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBERS AND DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE COMPLAINT OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED IN THE LABELING. BASED ON OUR EVALUATION, WE HAVE DETERMINED THAT AXSYM (B)(6) REAGENT, LIST NUMBER 7A40-22, LOT NUMBER 08233LF00 AND AXSYM CORE REAGENT, LIST NUMBER 7A41-20, LOT NUMBER 09228LF00 ARE PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    A NURSE RECEIVED SEROTHERAPY AFTER BEING PRICKED WITH A SAMPLING NEEDLE FROM A PATIENT WHO GENERATED REACTIVE RESULTS ON THE (B)(6) ASSAY AND GRAYZONE RESULTS ON (B)(6) CORE. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY AND CONFIRMED TO BE NEGATIVE FOR (B)(6) ON THE ARCHITECT ANALYZER. THE PATIENT WHO WAS THE SOURCE OF THE NEEDLESTICK HAD NEGATIVE (B)(6) SEROLOGY ON THE AXSYM TWO MONTHS AGO. NO ADVERSE OUTCOME WAS REPORTED DUE TO THE SEROTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CORE LOM ABBOTT LABORATORIES 09228LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AXSYM ANALYZER LIST # 7A83-82 SERIAL # (B)(4)