BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060316 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-01159
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLASMA SODIUM FLUORIDE 2.5ML GREY STOPPER CAPPED TUBE WAS USED. BASED ON DATA PROVIDED BY THE CUSTOMER, EVENT APPEARS TO BE A RESULT FROM SHORT SAMPLE. A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ONE (1) ERRONEOUSLY LOW GLUCM RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER, WHEN RUNNING IN DUPLICATE MODE. RERUN OF THE SAMPLE AFTER TUBE WAS UNCAPPED YIELDED A RESULT THAT MATCHED ONE OF THE PREVIOUS RESULT ORIGINAL RUN. RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1