BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2573637 · Received May 14, 2012

    Report

    Report Number
    2122870-2012-01302
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST REVIEW OF INSTRUMENT ARCHIVE DATA REVEALED THAT THE SUSPECT REAGENT PACK HAD BEEN SHARED BETWEEN LABORATORY INSTRUMENTS. BECKMAN COULTER INC. LABELING STATES: IF YOU ARE RELOADING A PARTIALLY USED REAGENT PACK, IT MUST BE RETURNED TO THE SAME STAND-ALONE SYSTEM OR ACCESS 2 WORKGROUP FROM WHICH IT WAS REMOVED. IF A PARTIALLY USED REAGENT PACK IS LOADED ON A DIFFERENT SYSTEM OR WORK GROUP, IT WILL BE INVENTORIED AS A FULL PACK AND INACCURATE RESULTS MAY OCCUR. THE CAUSE OF THIS EVENT IS USE ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DIGOXIN (DIG) PATIENT SAMPLES WOULD NOT RUN ON THEIR UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST TROUBLESHOOTING REVEALED THAT THE INSTRUMENT WAS ALSO EXPERIENCING A REAGENT PACK MONITORING ERROR "REAGENT PACK NO LONGER USABLE DUE TO PROCESS MONITORING FAILURE". THE CUSTOMER BELIEVE THAT THE REAGENT PACK IN QUESTION (LOT NUMBER 122057 AND SERIAL NUMBER (B)(4)) MAY HAVE BEEN LOADED ON THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM AFTER USE ON ANOTHER INSTRUMENT, THEREBY RESULTING IN THE INSTRUMENT ERRORS AND INABILITY TO RUN THE DIG ASSAY ON THE INSTRUMENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT ARCHIVE DATA CONFIRMED THAT THE REAGENT PACK HAD BEEN SHARED BETWEEN INSTRUMENTS. ONE PATIENT SAMPLE WAS TESTED ON THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM USING THE PACK SHARED DIG REAGENT PACK. THE INITIAL RESULT WAS NORMAL. THE INITIAL DIG RESULT WAS REPORTED FROM THE LABORATORY. ACTUAL REPEAT PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER HOWEVER, THEY INDICATED THAT UPON REPEAT TESTING, A SIMILAR VALUE WAS OBTAINED THEREBY CONFIRMING THE INITIAL RESULT AS VALID. 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 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1