BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2172279 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-03072
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED PERFORMANCE VERIFICATION TESTING WHICH FAILED FOR SAMPLE CARRYOVER. THE FSE REPLACED THE SAMPLE PROBE AND COLLAR WASH AND LUBRICATED THE LEAD SCREW ON ALL SYRINGE DRIVES. UPON REPAIR COMPLETION, THE INSTRUMENT WAS RETURNED INTO SERVICE. A DEFINITIVE ROOT CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUSLY HIGH CREATININE (CR-S) RESULT WAS GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE CRITICAL RERUN CR-S RESULT OF THE INITIAL RESULT, AS WELL AS TWO ADDITIONAL REPEAT RESULTS ON THE SAME INSTRUMENT, GENERATED LOWER RESULTS. THE SAME SAMPLE WAS TESTED ON ANOTHER INSTRUMENT IN DUPLICATE. THE CR-S RESULTS WERE LOWER, IN CONCURRENCE WITH THE CRITICAL RERUN RESULT, AND CONSIDERED VALID. ONE OF THE REPEAT RESULTS ON THE ALTERNATE MACHINE WAS REPORTED OUT OF THE LABORATORY. THE ERRONEOUSLY HIGH CR-S RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE SAMPLE WAS DRAWN IN A PRIMARY HEPARIN TUBE. THE SAMPLE LOOKED "NORMAL," THE PLASMA WAS CLEAR, AND THERE WAS NO EVIDENCE OF FIBRIN. THE SAMPLE WAS 27 MINUTES OLD AT THE TIME IT WAS INITIALLY RUN AND HAD BEEN STORED AT ROOM TEMPERATURE. SUBSEQUENT REPEAT TESTING OF THE SAMPLE WAS PERFORMED ON THE SAME PRIMARY TUBE. INSTRUMENT ANALYTE QUALITY CONTROLS RESULTS DURING THE TIMEFRAME OF THE EVENT WERE FOUND TO BE WITHIN SPECIFICATION. THE CUSTOMER MENTIONED RECEIVING A CC SYRINGE DRIVE "NO RESPONSE" ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR