BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2402971 · Received January 7, 2012

    Report

    Report Number
    2122870-2012-00046
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHS
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(6) 2011. THE FSE NOTED THE UNIT WAS OPERATING WITHOUT ISSUES. THE FSE VERIFIED REAGENT PIPETTOR ALIGNMENTS AND INSTRUMENT HARDWARE BY PERFORMING A SUCCESSFUL SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; CARRY OVER TESTING, AND CREATINE KINASE-MB (CK-MB) PRECISION TESTING WERE ALL WITHIN SPECIFICATIONS. THE UNIT CONFORMED TO THE MANUFACTURER'S 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 800 ACCESS IMMUNOASSAY SYSTEM. THE CK-MB RESULT DID NOT CORRELATE WITH THE PATIENT'S NORMAL CARDIAC TEST RESULTS AT THE TIME OF THE EVENT. THE CUSTOMER PERFORMED SYSTEM CHECK, AND THE RESULTS WERE WITHIN SPECIFICATIONS. SUBSEQUENT TESTING ON ACCESS 2 IMMUNOASSAY SYSTEM PRODUCED 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 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JHS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM| ACCESS CK-MB