BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110739 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-02084
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS BEEN ACCEPTABLE. PER DATA PROVIDED TO BCI, THIS APPEARED TO BE A SAMPLE-RELATED ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INCORRECT IMMUNOGLOBULIN (IGM) RESULT OF 8.43G/L GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WHICH REPEATED ON A DIFFERENT INSTRUMENT AT 37.3G/L WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1