BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2297205 · Received October 14, 2011

    Report

    Report Number
    2050012-2011-06056
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 14, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CHECKED THE CUSTOMER'S STOCK OF LABELS AND ONE MORE LABEL ROLL WAS REMOVED SINCE IT DID NOT SHOW BEC IMPRINT. FSE INSTALLED SECOND BARCODE READER AT THE DEVICE FOR DETECTION OF POTENTIAL INCORRECTLY LABELED TUBES. FSE WAS NOT ABLE TO RECONSTRUCT HOW LONG THE ALIEN LABELS HAD BEEN USED ON THE SYSTEM. THE ORIGIN OF THE ALIEN LABELS IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING AN EVENT THAT OCCURRED AS A RESULT OF PRINTING ERRORS CAUSED BY OPERATING THE AUTOMATE 2500 SYSTEM WITH NON BEC APPROVED LABELS. TWO DIFFERENT BARCODE LABELS WERE FOUND ATTACHED TO ONE SECONDARY TUBE. THE SECOND LABEL WAS DIRECTLY ATTACHED OVER THE FIRST LABEL. THE BARCODE LABELS WERE NOT FROM BEC. THE ERROR MESSAGE THAT WAS DISPLAYED BY THE SYSTEM AFTER THE UNSUCCESSFUL ATTEMPT TO APPLY A LABEL TO THE SECONDARY TUBE WAS NOT CORRECTLY FOLLOWED AND THE PRINTER WAS NOT ADEQUATELY INSPECTED. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY SINCE THE LABORATORY STAFF NOTICED THE DOUBLE LABELED TUBE AND PREVENTED IT FROM FURTHER PROCESSING AND CONDUCTED TESTING WITH THE ORIGINAL TUBE (PRIMARY TUBE). THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE JQP BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2500 S3I NA

    Patients

    Seq Age Sex Outcome Treatment
    1