BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2678276 · Received August 1, 2012

    Report

    Report Number
    2122870-2012-01641
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    July 7, 2012
    Report Date
    July 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE ACCESS 2 IMMUNOASSAY SYSTEM (ACCESS 2), GENERATED AN ERRONEOUS CK-MB RESULT FOR AN EMERGENCY ROOM PATIENT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS CORRECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT FOR THE PAST FEW WEEKS, THE WASHED PORTION OF THE SYSTEM CHECK FAILED THE FIRST TIME THE INSTRUMENT WAS RAN AND THEN THE SYSTEM CHECK PASSED UPON REPEAT. CUSTOMER REPORTED THAT ACCESS CK-MB REAGENT, LOT 123056, AND ACCESS CK-MB CALIBRATOR, LOT 119344, WERE USED IN CONJUNCTION WITH THE ACCESS 2 SYSTEM. BEC FIELD SERVICE ENGINEER (FSE), NOTED A FEW BUBBLES IN THE PIPETTOR LINE. THE FSE PROACTIVELY REBUILT THE PRECISION AND WASH PUMPS. THE FSE ALSO VERIFIED ALIGNMENTS AND ULTRASONICS. NO ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR