BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2304169 · Received October 21, 2011

    Report

    Report Number
    2050012-2011-06392
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE LEADING EDGE OF THE INSTRUMENT'S PRINT LABELER SUCTION PAD WAS DAMAGED AND HAD BEEN CORRECTED BY AN UNKNOWN SOURCE THROUGH THE APPLICATION OF TAPE. THIS CAUSED THE LABELS NOT TO FULLY TRANSFER AND LED TO THE MISLABELING INCIDENT. ADDITIONALLY IT WAS IDENTIFIED THAT THE INSTRUMENT WAS EQUIPPED WITH AN OUTDATED SOFTWARE VERSION, WHICH DID NOT POSSESS HIGHER SENSITIVITY MIS/LABELING ALERTS AVAILABLE IN NEWER VERSIONS OF THE SOFTWARE. THIS ISSUE WAS A CONTRIBUTING CAUSE TO THE MISLABELING EVENT. AS AN INTERIM REPAIR, A BARCODE READER WAS INSTALLED ON THE INSTRUMENT TO IDENTIFY ANY MISLABELED TUBES AND TO PREVENT THEM FROM FURTHER PROCESSING. SERVICE IS SCHEDULED TO INSTALL A LABEL PRESENT SENSOR AND TO REPLACE THE DAMAGED SUCTION PAD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A SECONDARY TUBE WAS LABELED WITH AN INCORRECT SAMPLE IDENTIFICATION BARCODE. TWO DIFFERENT BARCODE IDENTIFICATION CODES WERE APPLIED TO THE TUBE, WITH THE INCORRECT BARCODE OVER-LABELED ON TOP OF THE CORRECT BARCODE. THE MISLABELED ALIQUOT TUBE WAS DISCOVERED BY LABORATORY STAFF WHEN SAME PATIENT PRIMARY TUBE RESULTS DID NOT AGREE WITH SECONDARY TUBE SAMPLE CONDITION OR RESULTS. ALIQUOT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THE WRONG PATIENT BASED UPON THIS MISLABELING EVENT. THE END USER WAS INFORMED ABOUT THE EVENT AND OMITTED THE INCORRECTLY ASSIGNED PATIENT RESULTS. WHILE THERE WERE NO REPORTS OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN AS TO WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. PATIENT DEMOGRAPHIC INFORMATION, ACTUAL PATIENT RESULTS AND THE LABELS INVOLVED IN THE EVENT WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM LAB AUTOMATION JQP BECKMAN COULTER BIOMEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1