BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2212301 · Received August 15, 2011

    Report

    Report Number
    2122870-2011-02904
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS AT THE SITE WHEN THIS EVENT WAS DISCOVERED.THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DISPENSE PROBE. THE FSE PERFORMED A ROUTINE SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK AND A CARRYOVER TEST WITH ACCEPTABLE RESULTS. THE FSE PERFORMED A CALIBRATION AND QUALITY CONTROL ASSESSMENT FOR ALL ASSAYS. NO ISSUES WERE NOTED.ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    WHILE ON-SITE PERFORMING SCHEDULED PREVENTIVE MAINTENANCE, A BECKMAN COULTER INC. FIELD SERVICE ENGINEER (FSE) NOTED THAT THE UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM POSSESSED PINCHED DISPENSE PROBE #3 TUBING. THE TUBING APPEARED TO HAVE BEEN ROUTED CORRECTLY, BUT WAS STILL PINCHED. THE PINCHED TUBING RESULTED IN A FLOOD IN THE WASH CAROUSEL. THE INSTRUMENT HAD BEEN GENERATING 'DARK COUNT ERRORS' WHICH ARE INDICATIVE OF A FLOODED WASH CAROUSEL. THE CUSTOMER INDICATED THAT THEY HAD BEEN GENERATING QUALITY CONTROL RESULTS ONLY A THE TIME OF THIS EVENT, 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 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1