BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3011741 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00316
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED QC ISSUES DURING THE TIME THE EVENTS OCCURRED (BETWEEN (B)(4) 2013). BEC REVIEW OF THE CUSTOMER'S QC DATA INDICATES QC LEVEL 1 WAS OUTSIDE THE LABORATORY'S ESTABLISHED LIMITS ON (B)(4) 2013. THE CUSTOMER REPEATED QC ON (B)(4) 2013 TO OBTAIN AN ACCEPTABLE VALUE, BUT DID NOT REPEAT QC ON (B)(4) 2013, DESPITE QC LEVEL 1 BEING GREATER THAN 2.6 SD (STANDARD DEVIATION). QC FAILURES WERE ALSO OBSERVED IN THE DAYS PRIOR TO THE EVENT; THE CUSTOMER REPEATED QC ON THOSE DATES TO OBTAIN AN ACCEPTABLE VALUE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND EXCESSIVE AIR PRESENT IN THE WASH BUFFER DISPENSE LINES. FSE CLEANED THE WASH VALVE WHICH RESOLVED THE PROBLEM. THE LIKELY CAUSE FOR THIS EVENT MAY BE ATTRIBUTED TO THE FAILURE OF THE WASH VALVE ALLOWING AIR TO ENTER THE DISPENSE PROBE LINES. IN ADDITION, OPERATOR ERROR IN NOT APPROPRIATELY MONITORING ACCUTNI QC MAY HAVE CONTRIBUTED TO THE EVENT. MDR #2122870-2013-00314 DOCUMENTS THE RESULTS FOR PATIENT 2 OF 3 INVOLVED IN THIS EVENT. MDR #2122870-2013-00315 DOCUMENTS THE RESULTS FOR PATIENT 3 OF 3 INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT ERRONEOUS TROPONIN I (ACCUTNI) AND CKMB RESULTS FOR 3 PATIENTS GENERATED BY AN ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ERRONEOUS ACCUTNI RESULTS FOR ALL 3 PATIENTS AND ERRONEOUS ACCUTNI AND CKMB RESULTS FOR PATIENT 3. THIS REPORT DOCUMENTS THE RESULTS FOR PATIENT 1 OF 3. SEPARATE REPORTS HAVE BEEN SUBMITTED TO DOCUMENT THE RESULTS FOR THE OTHER 2 PATIENTS INVOLVED IN THIS EVENT. THE CUSTOMER DECLINED TO PROVIDE RESULT DATA FOR PATIENT 1 EXCEPT THAT THE ORIGINAL RESULT WAS "POSITIVE" AND THE REPEAT RESULT WAS "NEGATIVE." THE CUSTOMER DID NOT BELIEVE THERE WAS ANY CHANGE TO OR IMPACT TO PATIENT TREATMENT DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114221 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1