BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1980927 · Received February 7, 2011

    Report

    Report Number
    2122870-2011-00335
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN LI HEP PLASMA TUBES WITHOUT GEL SEPARATOR. PER CUSTOMER, THE SAMPLES WERE FULL DRAWS AND DID NOT APPEAR LIPEMIC. ALL THREE LEVELS OF QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SUBSTRATE PROBE AND TUBING. FSE ALSO ADJUSTED THE BUBBLE DETECTOR AND PERFORMED HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE RECALIBRATED THE ASSAY AND PERFORMED QC; NO ISSUES WERE REPORTED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(4) 2010 - (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES. THIS REPORTABLE EVENT CAPTURES PATIENT #2 RESULTS THAT ARE RELATED TO THE PREVIOUSLY SUBMITTED MDR 2122870-2010-00745.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED CREATININE KINASE - MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OF CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1