BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180388 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02589
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTED THE ACCUTNI SAMPLES IN 7ML BD SERUM TUBES WITH A GEL SEPARATOR. ACCUTNI QC HAS BEEN WITHIN THE CUSTOMER ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. CPLS PERFORMED INTERFERENCE TESTING WHICH REVEALED TWO KINDS OF INTERFERENCES: A HETEROPHILE INTERFERENCE AND AN INTERFERENCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND DISTINCT FROM HETEROPHILE ANTIBODIES CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS. AS FOR HETEROPHILE ANTIBODIES INTERFERENCE, THE RESULTS DO NOT CORRELATE WITH THE CLINICAL STATUS OF THE PATIENT. CUSTOMER IS NOT QUESTIONING INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFRACTION (AMI) CUT-OFF FOR ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE CARDIAC CARE UNIT FOR FURTHER EVALUATION. NO CARDIAC ABNORMALITY WAS FOUND. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND ALTERNATE METHODOLOGY. THE SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED DISCORDANT, LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization