BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1905061 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00741
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE THAT WAS CENTRIFUGED AT 5,800 RPM FOR 10 MINUTES. QC AND SYSTEM CHECKS PERFORMED ON (B)(4) 2010 AND (B)(4) 2010 WERE WITHIN THE ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE STATED THAT THE SAMPLE WAS VERY HEMOLYZED AND NOTED SOME FLOATING STRANDS OF FIBRIN. PRE-ANALYTICAL SAMPLE HANDLING WAS DISCUSSED WITH CUSTOMER. THE FSE RAN 20 REPLICATES OF WASH BUFFER FROM THE ACCUTNI REAGENT PACK THAT PRODUCED THE ERRONEOUS RESULT. ALL RESULTS WERE 0.00NG/ML. THE FSE RAN 50 REPLICATES OF WASH BUFFER FROM A NEW ACCUTNI REAGENT PACK RECOVERING ACCEPTABLE RESULTS. THE FSE PERFORMED A DIAGNOSTIC TEST AND ALL PORTIONS PASSED WITHIN SPECIFICATIONS. ALTHOUGH SAMPLE INTEGRITY IS IN QUESTION, NO DEFINITIVE ROOT CAUSE FOR THIS EVENT CAN BE DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND RECOVERED LOWER WITHIN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULT WAS NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1