BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 2008664 · Received March 7, 2011

    Report

    Report Number
    2122870-2011-00590
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    November 21, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED BY THE CUSTOMER. QC WAS NOT SUPPLIED. PER THE CUSTOMER, THE SAMPLE WAS INITIALLY PROCESSED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). PER THE CUSTOMER, THE INITIAL RESULT CAME FROM THE FIRST REPLICATE OF A NEW ACCUTNI REAGENT PACK. THIS EVENT WAS PRESENTED TO THE BCI REVIEW TEAM ON (B)(6) 2011 AND IS CURRENTLY UNDER INVESTIGATION BY BCI. ROOT CAUSE IS PENDING TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A LOWER THAN EXPECTED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUT-OFF ON ONE PATIENT THAT WAS GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. HIGHER RESULTS, WHICH INDICATED IMPRECISION, ABOVE THE AMI CUT-OFF WERE OBTAINED UPON REPEAT ANALYSIS. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AFFECT TO PATIENT TREATMENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM. DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1