BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2221107 · Received August 23, 2011

    Report

    Report Number
    2122870-2011-03085
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER DECLINED SERVICE AS THEY FELT THE IMPRECISE/ERRONEOUS RESULT WAS SAMPLE RELATED. THE SAMPLE WAS SENT INTO BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT FOR INTERFERENCE TESTING. THE RESULTS OF THIS TESTING HAVE NOT BEEN PROVIDED TO DATE. ALTHOUGH SAMPLE ISSUES ARE SUGGESTED AS A CAUSE FOR THIS EVENT, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED/IMPRECISE CREATINE KINASE-MB ISOENZYME (CK-MB) RESULT WAS GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL RESULT WAS ELEVATED AND ABOVE THE NORMAL REFERENCE RANGE FOR THE ASSAY. THE INITIAL CK-MB RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. UPON MULTIPLE REPEAT TESTING ON THE SAME INSTRUMENTATION, AS WELL AS ON ANOTHER INSTRUMENT, THE RESULTS WERE STILL ABOVE THE NORMAL REFERENCE RANGE BUT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLE WAS COLLECTED IN A SODIUM HEPARIN PLASMA TUBE WITH A GEL BARRIER AND WAS CENTRIFUGED PRIOR TO TESTING. THE SAMPLE APPEARED NORMAL WITH ICTERIA, LIPEMIA, AND HEMOLYSIS SCALE RESULTS OF ONE. ALL LEVELS OF INSTRUMENT CK-MB QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. THE CUSTOMER BELIEVES THAT THE ELEVATED AND IMPRECISE RESULT WAS THE RESULT OF PATIENT CONDITION. THE PATIENT WAS SEPTIC AND AT THE END STAGES OF RENAL FAILURE. THE PATIENTS CREATININE AND MODULAR BLOOD UREA NITROGEN (BUN) RESULTS WERE HIGHLY ELEVATED DUE TO THEIR STATE OF HEALTH. THESE RESULTS WERE NOT REGARDED AS ERRONEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ACCESS CK-MB REAGENT