BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2022763 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00775
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 15, 2011
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOMATE SYSTEM WAS SHIPPED TO CUSTOMER IN (B)(6) 2009; HOWEVER, IT WAS INSTALLED IN (B)(6) 2011. THE PRINTER MOUNTED ON THE DEVICE WAS FINAL INSPECTED BY THE MANUFACTURER IN JAN 2009. THE LABEL ROLL STAYED ON THE PRINTER UNIT THE SYSTEM WAS INSTALLED. THE EXPIRY DATE OF THE LABEL ROLL IS 2 YEARS AFTER MANUFACTURING. THE EXPIRED LABEL ROLL CAUSED LABEL JAMS ON THE PRINTER. THE CUSTOMER RECEIVED MULTIPLE ERROR MESSAGES FROM THE PRINTER IN REGARDS TO MISSING LABELS, WHICH WAS DISREGARDED. SINCE THE USER DID NOT ADDRESS THE RECOVERY OF THE JAMMED LABELS CORRECTLY, IT CAUSED A SECONDARY TUBE TO BE LABELED WITH TWO DIFFERENT BARCODES. TUBE WAS VISUALLY NOTICED BY OPERATOR AND PREVENTED FROM FURTHER PROCESSING. AN OPTIONAL EQUIPMENT OF A SECOND BARCODE SCANNER, WHICH WOULD HAVE DETECTED THE TUBE AND PREVENTED IT FROM FURTHER PROCESSING, WAS NOT INSTALLED AT THE DEVICE. THE SYSTEM MALFUNCTION WAS A DIRECT RESULT OF THE USE OF EXPIRED LABELS. THESE LABELS SHOULD NOT HAVE BEEN USED IN THE OPERATION OF THE SYSTEM. THE USE OF THE EXPIRED LABELS RESULTED IN THE INABILITY TO PROPERLY FUNCTION. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE EXPIRED LABELS WITH LABELS WITHIN THE USEABLE DATES FOR THE PRODUCT AND CHECKING THE ALIGNMENT OF THE PRINTER. THE SYSTEM CONTINUED TO OPERATE WITH NO DIFFICULTIES. THE CUSTOMER WAS INSTRUCTED TO CHECK THE PRINTER AND LABEL APPLICATOR WHEN ERROR MASSAGES POPS UP ON THE SCREEN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A DOUBLE LABELING OF A SECONDARY TUBE WITH TWO DIFFERENT BARCODES BY THE BECKMAN COULTER LAB AUTOMATION SYSTEM AUTOMATE 2500. NO IMPACT TO PATIENT OR OPERATOR; TUBE WAS PREVENTED FROM FURTHER PROCESSING.

    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