BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1882157 · Received October 25, 2010

    Report

    Report Number
    2050012-2010-01042
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 25, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CUSTOMER'S QC SHOWED THAT THE QC HAD BEEN DEMONSTRATING IMPRECISION PRIOR TO THE EVENT. A SERVICE TESTING INDICATED CARRYOVER. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SAMPLE SYRINGE BODY, MIXER PADDLES, REAGENT PROBE AND WASH COLLARS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT DIGOXIN (DIGN) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT. THE INITIAL RESULT OF 0.9 NG/ML WAS REPORTED OUT OF THE LABORATORY. WHEN QC WAS ERRATIC, A TECHNICIAN RERAN THE SAMPLE 3 TIMES, AND OBTAINED RESULTS OF 2.1, 1.2, AND 1.9 NG/ML. A SUBSEQUENT TESTING AT ANOTHER LAB PRODUCED RESULT OF 1.0 NG/ML. NO RESULT WAS AMENDED. THERE WAS NO EFFECT TO THE PATIENT OR THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1