BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2073404 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01235
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    June 23, 2009
    Report Date
    April 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    2050012-04/15/2011-017C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT DATA OR RESULTS WERE SUPPLIED. NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED. QC SHIFTED HIGH OUT OF THE CUSTOMER'S ESTABLISHED RANGES. WHILE TROUBLESHOOTING WITH THE CUSTOMER, AN AIR CONDITIONING VENT WAS FOUND TO BE BLOWING COLD AIR DIRECTLY ON ONE OF THE INSTRUMENTS. ONCE THE AIR CONDITIONING VENT WAS TURNED OFF AND THE TEMPERATURE DIFFERENCE BETWEEN THE 2 INSTRUMENTS REDUCED, QC WAS WITHIN THE ESTABLISHED RANGE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 - OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING TROPONIN (ACCUTNI) QUALITY CONTROL RESULTS SHIFTING HIGHER FOR ONE INSTRUMENT AS COMPARED TO THE OTHER. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1