BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2636576 · Received July 2, 2012

    Report

    Report Number
    2122870-2012-01536
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON THE SAME DAY. THIS REPORT IS RELATED TO MDR# 2122870-2012-01510.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED ERRONEOUS CREATINE KINASE-MB (CK-MB) PATIENT RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE RELEASED FROM THE LABORATORY AND AMENDED REPORTS WERE FILED AFTER THE SAMPLES WERE REPEATED. CUSTOMER REPORTED THAT THERE WERE NO QUALITY CONTROL (QC) ISSUES. CUSTOMER REPORTED THAT THEY WERE RUNNING CK-MB REAGENT LOT 123056 AND CK-MB CALIBRATOR LOT 119344 ON THIS INSTRUMENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED A HIGH SENSITIVITY SYSTEM CHECK; THE SYSTEM CHECK SHOWED ALL PARAMETERS PASSED WITHIN SPECIFICATIONS. THE FSE DID NOT FIND ANY HARDWARE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1