BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2190007 · Received August 3, 2011

    Report

    Report Number
    2122870-2011-02648
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DID NOT COMPLETE ANY REPAIRS AT THE TIME OF SERVICE. THE FSE PERFORMED A CARRY OVER TEST AND HIGH SENSITIVITY SYSTEM CHECK WHICH GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A 10 REPLICATE CKMB PRECISION RUN ON ALL 4 PIPETTORS WITH ACCEPTABLE RESULTS. THE FSE PERFORMED A CKMB QUALITY CONTROL ASSESSMENT WHICH GENERATED RESULTS WITHIN THE CUSTOMERS ESTABLISHED LIMITS AS FINAL VERIFICATION THAT HARDWARE WAS PERFORMING WITHIN INSTRUMENT SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 IMPRECISE CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEMS FOR TWO PATIENT SAMPLES. INITIAL CK-MB RESULTS FOR BOTH PATIENTS WERE ELEVATED AND OUTSIDE THE NORMAL REFERENCE RANGE. REPEAT TESTING OF THE PATIENT SAMPLES ON THE SAME INSTRUMENT RE-PRODUCED THE ELEVATED RESULTS, HOWEVER, THE REPEAT TEST RESULTS DID NOT REPRODUCE WITHIN THE STATED CKMB ASSAY PRECISION CLAIMS FOR EITHER PATIENT SAMPLE. PATIENT NUMBER ONE'S SAMPLE WAS ALSO TESTED ON ANOTHER INSTRUMENT. THE RESULTS OF THIS INSTRUMENT ARE NOT IN QUESTION AS BEING EITHER ERRONEOUS OR IMPRECISE. ALTHOUGH IMPRECISE RESULTS WERE REPORTED OUT OF THE LABORATORY THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED WITH THIS EVENT. INSTRUMENT CK-MB QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT ALSO MET SPECIFICATIONS. THE CK-MB SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES WITH GEL SEPARATOR, AND WERE CENTRIFUGED PRIOR TO TESTING. NO PATIENT SPECIFIC INFORMATION WAS PROVIDED BY THE CUSTOMER.

    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 ACCESS CK-MB REAGENT