BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1645948 · Received March 30, 2010

    Report

    Report Number
    2122870-2010-00118
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES TESTED WERE SERUM AND PLASMA.CUSTOMER STATED THERE WERE NO ERRORS POSTED TO THE EVENT LOG AND QC WAS WITHIN SPECIFICATIONS. CUSTOMER IS NOT QUESTIONING ANY OTHER ASSAYS OR RESULTS AT THIS TIME.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE VERIFIED ALIGNMENTS AND CLEANED THE WASH CUPS. B) THE FSE PERFORMED A DIAGNOSTIC TESTING AND QC AND ALL RESULTS MET SPECIFICATIONS.A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE ON ONE PATIENT'S SAMPLE. A) THE RESULT WAS REPORTED OUT OF THE LAB.UPON REPEAT ON A DIFFERENT INSTRUMENT, THE CKMB RESULTS WERE IN THE NORMAL REFERENCE RANGE. A) A CORRECTED REPORT WAS ISSUED.NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JHS BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1