BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2219375 · Received August 22, 2011

    Report

    Report Number
    2122870-2011-03076
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT THE SAMPLE IDLER PULLEY HAD BROKEN. IT IS UNKNOWN WHEN THE BREAKAGE HAD OCCURRED. THE SAMPLE IDLER PULLEY AND MOTOR BELT WERE REPLACED. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE COMPLETION OF THE NECESSARY REPAIRS. ALTHOUGH HARDWARE WAS LIKELY A CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03071, 2122870-2011-03072, 2122870-2011-03073, 2122870-2011-03074, 2122870-2011-03075, 2122870-2011-03076, 2122870-2011-03077, 2122870-2011-03078, 2122870-2011-03079, 2122870-2011-03080, 2122870-2011-03081, 2122870-2011-03082, 2122870-2011-03083, 2122870-2011-03084.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS AND/OR IMPRECISE FOLATE, BR MONITOR, ALPHA-FETOPROTEIN (AFP), OV MONITOR, FERRITIN OR VITAMIN B12 (VIT B12) RESULT WAS GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM FOR FOURTEEN PATIENT SAMPLES ON (B)(6) 2011. THIS IS REPORT SIX OF FOURTEEN AND REPRESENTS THE SECOND IMPRECISE OV MONITOR PATIENT RESULT GENERATED FOR A PATIENT SAMPLE ON (B)(6) 2011. THE INSTRUMENT GENERATED MULTIPLE ERROR MESSAGES THAT CAUSE THE CUSTOMER TO PERFORM REPEAT TESTING OF PREVIOUSLY GENERATED PATIENT RESULTS. UPON REPEAT TESTING, A PREVIOUSLY REPORTED INITIAL OV MONITOR RESULT WITHIN THE NORMAL REFERENCE RANGE RECOVERED WITH A HIGHER RESULT, WITHIN THE SAME CLINICAL RANGE, BUT OUTSIDE OF THE STATED PRECISION CLAIM OF THE ASSAY. INFORMATION PROVIDED BY THE BECKMAN COULTER INC FIELD SERVICE ENGINEER SUGGESTS THAT THE PATIENT MAY HAVE RECEIVED TREATMENT BASED UPON THE INITIAL, QUESTIONABLE RESULT. ALTHOUGH IT IS UNKNOWN AS TO WHAT, IF ANY, MEDICAL TREATMENT WAS INITIATED BASED UPON THE OV MONITOR RESULTS, FOR THE PURPOSES OF THIS REPORT IT IS ASSUMED THAT MODIFICATION TO PATIENT TREATMENT OCCURRED. THE SAMPLE WAS COLLECTED IN A 13 X 75 MM PLASTIC TUBE. ALL LEVELS OF INSTRUMENT OV MONITOR QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. PRIOR TO THE EVENT, THE INSTRUMENT GENERATED A "PUMP PISTON EXCESSIVE SLIPPAGE" ERROR, HOWEVER THE CUSTOMER WAS ABLE TO INITIALIZE THE SYSTEM AND CONTINUE TO OPERATE THE INSTRUMENT. THE INSTRUMENT SUBSEQUENTLY GENERATED A NUMBER OF "ASPIRATION MONITOR DETECTED POSSIBLE OBSTRUCTION- SAMPLE PUMP" ERRORS. NO SPECIFIC PATIENT 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 Required Intervention ACCESS OV MONITOR REAGENT