BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2073407 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01234
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    May 15, 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 AND NO QC OR SYSTEM CHECK DATA WAS SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE. A DIFFERENCE OF 5 DEGREES C WAS NOTED BETWEEN THE UPPER CASE OF EACH INSTRUMENT. THE TEMPERATURE DIFFERENCE WAS RESOLVED BY TURNING OFF THE A/C THAT WAS BLOWING DIRECTLY ON THIS SYSTEM. A DIFFERENCE IN CASE AND AMBIENT TEMPERATURE WAS THE ROOT CAUSE FOR THIS EVENT. 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 THERE WAS A DIFFERENCE IN DOSE RESPONSE BETWEEN THEIR TWO INSTRUMENTS. BOTH SYSTEMS WERE USING THE SAME REAGENT AND CALIBRATOR LOTS. IT IS UNKNOWN WHETHER THERE WAS AN 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