BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230313 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03355
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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) NOTED INTERMITTENT WASH VALVE AND WASH PUMP MOTION ERRORS IN THE EVENT LOG, AND AIR IN ALL THREE DISPENSE PROBE TUBES. THE FSE REMOVED, INSPECTED, CLEANED AND REBUILT THE WASH PUMP COMPONENTS. THE FSE CLEANED THE ASPIRATE PROBES AND PRIMED THE WASH LINES WITH 20 PRIMING CYCLES. NO FURTHER AIR BUBBLES WERE OBSERVED IN THE LINES. THE FSE PERFORMED A PASSING SYSTEM CHECK WITH RESULTS WITHIN INSTRUMENT SPECIFICATIONS AND A PASSING QUALITY CONTROL ASSESSMENT WITH RESULTS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. THE FSE ALSO PERFORMED A PASSING HIGH SENSITIVITY SYSTEM CHECK WITH RESULTS WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH HARDWARE REPAIRS WERE COMPLETED AT THE TIME OF SERVICE A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03355, 2122870-2011-03356.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ELEVATED CARDIAC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THIS IS REPORT ONE OF TWO AND REPRESENTS THE ERRONEOUSLY ELEVATED ACCUTNI RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE ON (B)(6) 2011. THE CUSTOMER QUESTIONED THE INITIAL ACCUTNI RESULT AFTER THE INSTRUMENT ASSAY QUALITY CONTROL RESULTS FAILED TO PERFORM WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE INITIAL ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS IN TRANSIT TO ANOTHER FACILITY, BASED UPON THE ERRONEOUS ACCUTNI RESULT, WHEN THE REPEAT ACCUTNI TESTING WAS ORDERED. IT IS UNKNOWN WHETHER THERE WAS MODIFICATION TO PATIENT TREATMENT AS PART OF THE TRANSFER. REPEAT TESTING OF THE PATIENT SAMPLE AT A DIFFERENT SITE PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO, AND ON THE DAY OF, THE EVENT PASSED INSTRUMENT ESTABLISHED SPECIFICATIONS. THE INITIAL SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA GREEN TOP TUBE AND CENTRIFUGED PRIOR TO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESS ACCUTNI