BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2891917 · Received December 31, 2012

    Report

    Report Number
    2122870-2012-02028
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE: WASH PUMP, WASH CAROUSEL PULLEYS AND PINCH ROLLERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE TROPONIN I (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ON (B)(6) 2012 FOR A TOTAL OF TWO PATIENTS. THE CUSTOMER REPORTED REPEAT TESTING OF THE PATIENT SAMPLES WAS WITHIN THE NORMAL RANGE OF THE ASSAY FOR BOTH PATIENTS. THE CUSTOMER SUPPLIED ERRONEOUS RESULTS FOR THE TWO PATIENTS WHICH WERE GENERATED AFTER A PREVENTIVE MAINTENANCE (PM) HAD BEEN COMPLETED ON (B)(6) 2012. THE CUSTOMER HAD ALSO COMPLAINED OF ONGOING HARDWARE CONCERNS AFTER THE PM WAS COMPLETED WHEREBY SYSTEM CHECKS WERE BARELY PASSING BASED ON THE DATA SUPPLIED BY THE CUSTOMER. THE CUSTOMER HAD SUPPLIED A SYSTEM CHECK RESULTS WHICH WERE GENERATED ON (B)(6) 2012 WHICH HAD INITIALLY FAILED TO PASS WITHIN SPECIFICATIONS AND WERE REPEATED TO PASS ON THE SAME DATES. THIS REPORT IS FOR THE EVENT WHICH OCCURRED ON (B)(6) 2012. PLEASE SEE MEDWATCH #2122870-2012-02029 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2012. THE CUSTOMER OBTAINED A FALSE POSITIVE ACCUTNI RESULT OF 0.418 NG/ML FOR ONE EMERGENCY ROOM PATIENT ON (B)(6) 2012. UPON REPEAT TESTING OF THE PATIENT SAMPLE, THE CUSTOMER OBTAINED A RESULT OF 0.032 NG/ML. THE ERRONEOUS INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY BUT A CORRECTED REPORT WAS RELEASED 40 MINUTES AFTER THE INITIAL RESULT WAS REPORTED. THE CUSTOMER INDICATED THAT THERE WERE NO CHANGES IN PATIENT TREATMENT AND NO AFFECT TO PATIENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER NOTED THAT THERE WERE NO SAMPLE INTEGRITY ISSUES REPORTED AND QUALITY CONTROL (QC) WAS PASSING WITHIN THE CUSTOMER'S LIMITS AT THE TIME OF THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED ISSUES WITH THE INSTRUMENT HARDWARE. SYSTEM CHECKS FAILED FOR THE FSE ON (B)(4) 2012. THE FSE REPLACED THE INSTRUMENT WASH PUMP COMPONENTS AFTER BUBBLE FORMATION WAS OBSERVED IN THE PUMP. THE FSE INDICATED SYSTEM CHECKS STILL FAILED AND PROCEEDED TO REPLACE THE INSTRUMENT WASH CAROUSEL PULLEYS AND PINCH ROLLERS. THE FSE INDICATED THAT SYSTEM CHECKS WERE PASSING AFTER ALL HARDWARE REPLACEMENTS WERE COMPLETED AND INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR