BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1992274 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00392
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN INTO A LITHIUM HEPARIN TUBE QC RESULTED WITHIN RANGE DURING THE TIME OF THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 RESULTED WITHIN SPECIFICATIONS. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. THE CUSTOMER SENT SAMPLE FROM THE PATIENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TESTING WITH ELIMINATING PROTEINS CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT AS THE ROOT CAUSE FOR THE PATIENT'S ELEVATED CKMB RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING CKMB RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ON ONE PATIENT'S SAMPLE. THE SPECIMEN WAS TESTED BY AN ALTERNATE METHODOLOGY AND CKMB RESULT OBTAINED WAS IN A DIFFERENT CLINICAL RANGE. THE CUSTOMER DID NOT REPORT AFFECT 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1