BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1863330 · Received October 9, 2010

    Report

    Report Number
    2050012-2010-00964
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    September 11, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SYSTEM ISSUE WAS REPORTED BY THE CUSTOMER. A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO AN ERRONEOUSLY LOW GLUCOSE (GLUCM) RESULT GENERATED BY UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 27 MG/DL AND THE RE-RUN RESULT WAS 95 MG/DL. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE TEST WAS REPEATED IN DUPLICATE AND THE RESULTS WERE 93 AND 92MG/DL. THE RESULT OF 93 MG/DL WAS REPORTED. THERE WAS NO EFFECT TO THE PATIENT OR TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1