BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 1857125 · Received October 6, 2010

    Report

    Report Number
    2050012-2010-00929
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IGNORED THE ERROR MESSAGE AND DID NOT PROPERLY RECOVER FROM THE ERROR. THE BCI INSTRUMENT PERFORMED AS EXPECTED AND GENERATED THE EXPECTED MESSAGE. THE ISSUE WAS RESOLVED SO SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TWO BARCODE LABELS WITH DIFFERENT BARCODES WERE FOUND ATTACHED TO ONE SECONDARY TUBE THAT WAS GENERATED BY THE AUTOMATE 2500 S3I, SORTER AND ALIQUOTER. A LABEL FAILURE OCCURRED DURING THIS EVENT AND AN ERROR MESSAGE WAS DISPLAYED FOR THE USER. BECAUSE THE TWO LABELS WERE ATTACHED ON TOP OF EACH OTHER, CREATING A GREATER THICKNESS, THE LAB STAFF DETECTED THE DOUBLE LABELED TUBE AND WAS ABLE TO PREVENT FURTHER PROCESSING. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM LAB AUTOMATION JQP BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1