BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2122012 · Received May 24, 2011

    Report

    Report Number
    2050012-2011-01906
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 15, 2010
    Report Date
    May 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    Removal / Correction Number
    Z-2441-42-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SERUM. QC AND PRECISION CHECKS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND RAN A CENTRIFUGE TUBE ALIQUOTTER (CTA) CARRYOVER TEST WHICH FAILED. FSE THEN REPLACED THE CTA SAMPLE PROBE AND PERFORMED ALIGNMENTS AFTER WHICH A REPEAT OF THE CARRYOVER TEST PASSED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE HIGH TROPONIN (ACCUTNI) RESULTS. THE RESULTS FOR THIS EVENT WERE REPORTED ON MDR# 2050012-2010-00292. THE TEST RESULTS ARE FOR THE MALFUNCTION DATED (B)(6) 2010. THE RESULTS WERE NOT RELEASED FROM THE LAB AND THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY OR DEATH. THE CUSTOMER REDACTED THE PT IDENTIFIERS SUCH AS DOB OR AGE AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER, PRODUCT CODE: JJE MMI BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1