BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2103582 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01895
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN IN A GREEN TOP TUBE AND WAS CLEAR. QC WAS WITHIN ESTABLISHED RANGES BEFORE AND AFTER THE EVENT. SERVICE WAS NOT CALLED FOR THIS EVENT. SAMPLE IS BEING SENT IN FOR INVESTIGATION. ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT CREATININE (CREM) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM AND CREATININE (CR-S) RESULT FOR ONE PATIENT SAMPLE DID NOT MATCH. THE PATIENT HAS BEEN RUNNING A HIGH CREATININE SO THE CREM WAS REPORTED OUT OF THE LAB. THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1