BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1890373 · Received November 3, 2010

    Report

    Report Number
    2122870-2010-00686
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE SPECIFICATIONS. THE SAMPLE WAS PLASMA. THE CUSTOMER STATED THAT A CLOT WAS OBSERVED IN THE SAMPLE PRIOR TO RE-CENTRIFUGATION. THE CUSTOMER IS AWARE OF SAMPLE HANDLING GUIDE RECOMMENDATIONS AND HAS INSTRUCTED THE LAB STAFF. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING WAS A ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED ON ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. A SUBSEQUENT TESTING AFTER RE-SPUN OF THE SAMPLE PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT REPORT EFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1