BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2180149 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02421
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN WITH A GEL BARRIER THAT WAS CENTRIFUGED AT 3250RPM FOR 7 MINUTES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011. FSE PERFORMED ALIGNMENTS, A SYSTEM CHECK AND PIPETTOR VERIFICATIONS AND ALL TESTING MET SPECIFICATIONS. THE CARRYOVER PROCEDURE PERFORMED FAILED. FSE REPLACED THE SAMPLE PROBE, CHECKED ALIGNMENTS AND CLEANED PROBE AFTER WHICH CARRYOVER PROCEDURE REPEATED FAILED AGAIN. FSE THEN CLEANED THE PROBE, RAN A SPECIAL CLEAN AND REPEATED THE CARRYOVER PROCEDURE WHICH PASSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A DISCREPANT TSH (THYROID STIMULATING HORMONE) RESULT BELOW THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. REPEAT TESTING ON TWO ALTERNATE ANALYZERS RESULTED LOWER. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1