BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2466552 · Received February 23, 2012

    Report

    Report Number
    2122870-2012-00496
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 29, 2012
    Report Date
    January 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2012 AND DISCOVERED REAGENT PIPETTOR #2 WAS TOUCHING THE SIDE OF THE REACTION VESSELS (RV), THE SIDE OF THE REAGENT PACKS, THE SIDE OF THE WASH STATION AND THE SIDE OF THE REAGENT PICKUP HOLES. THE FSE REPLACED THE TRANSDUCER FOR REAGENT PIPETTOR #2 AND PERFORMED ALL NECESSARY VERIFICATION TESTING. THE FSE PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN THE SYSTEM SPECIFICATIONS. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED CREATINE KINASE-MB (CK-MB) RESULT, ABOVE THE NORMAL REFERENCE INTERVAL, FOR ONE PATIENT INVOLVING UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE ELEVATED RESULT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PRESENTATION. SUBSEQUENT TESTING ON AN ALTERNATE SYSTEM RECOVERED A LOWER RESULT WITHIN THE NORMAL REFERENCE INTERVAL. THE ELEVATED RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS CK-MB CALIBRATORS| ACCESS CK-MB