BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2033876 · Received March 30, 2011

    Report

    Report Number
    2122870-2011-00694
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN BD SST SERUM GOLD TOP TUBE. QC HAS BEEN RECOVERING WITHIN ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS PREVIOUSLY ON-SITE AND PERFORMED A MINOR PREVENTIVE MAINTENANCE (PM) ON (B)(6) 2011. SYSTEM CHECK DATA PASSED ALL SPECIFICATIONS FOLLOWING THE PM. FSE RETURNED ON-SITE AFTER THE EVENT (ON (B)(6) 2011) AND RAN SYSTEM CHECK. ALL VERIFICATION PASSED ALL PARAMETERS AND NO HARDWARE ISSUES WERE IDENTIFIED. A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A FALSE POSITIVE CKMB RESULT GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT REPORTED IN CONNECTION WITH 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