BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2122593 · Received June 14, 2011

    Report

    Report Number
    2050012-2011-02271
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE INSTRUMENT'S TUBE TRANSFER UNIT (TTU) WAS NOT INDEXING TUBES CORRECTLY, AND NOT INTERFACING CORRECTLY WITH THE BRUSHES THAT ATTACH THE LABELS. THE TTU WAS LUBRICATED. PERFORMANCE TESTING WAS PERFORMED WITH ACCEPTABLE RESULTS HOWEVER THE REPAIR DID NOT RESOLVE THE ISSUE. SUBSEQUENTLY A NEW TTU AND CAN CONTROL MODULE WERE ORDERED FOR REPLACEMENT. THE FSE ALSO NOTED THAT THE INSTRUMENT'S SECOND BARCODE READER, WHICH DETECTS MISLABELED TUBES AND PREVENTS THEM FROM FURTHER PROCESSING, WAS DEACTIVATED BY CUSTOMER SERVICE STAFF. THE FSE ACTIVATED THE MISLABELING BARCODE READER AND ADJUSTED IT FOR OPTIMAL READING RATE. THE SECONDARY BARCODE READY WILL ALERT THE CUSTOMER TO ANY POTENTIALLY MISLABELED TUBES. THE FACT THAT THE MISLABELED TUBE WAS ALIQUOTTED EVEN THOUGH IT WAS POSITIONED IN THE SYSTEMS ERROR WORKPLACE OF THE SYSTEM, IMPLIES THAT USER/SYSTEM INTERFACE WAS A CONTRIBUTING CAUSE TO THIS EVENT. ALTHOUGH THE INSTRUMENT WAS REPAIRED AND RETURNED INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN IDENTIFIED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ALIQUOT TUBE WAS DOUBLE LABELED WITH TWO UNIQUE IDENTIFICATION CODES. BARCODE LABEL # (B)(6) WAS APPLIED TO ALIQUOT TUBE # (B)(6). THE MISLABELLED ALIQUOT TUBE WAS DISCOVERED BY LABORATORY STAFF. THE TUBE WAS PLACED IN THE ERROR WORKPLACE BY THE SYSTEM, HOWEVER, WAS MANUALLY ALIQUOTTED BY STAFF. UPON ALIQUOTTING THE TUBE, A DISTINCT COLOR DIFFERENCE WAS NOTED BETWEEN THE PRIMARY SAMPLE AND THE ALIQUOT SAMPLE. RESULTS ASSOCIATED WITH THIS EVENT WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1