BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1853383 · Received October 5, 2010

    Report

    Report Number
    2122870-2010-00591
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER'S SUPPLIED QC CHARTS, ALL LEVELS OF ACCUTNI QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 09/08/2010 FOR THIS EVENT. THE FSE REPLACED THE INCUBATOR BELT BEARINGS, VESSEL HOLDERS AND CALIBRATED THE BELT DUE TO A NOISY INCUBATOR BELT. THE FSE DID NOT NOTE ANY HARDWARE ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH ACCUTNI RESULT ABOVE THE AMI CUT-OFF FOR ONE PATIENT THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. ACCUTNI WAS REPEATED AND THE RESULT WAS IN THE NORMAL REFERENCE RANGE. THE ORIGINAL ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY, BUT AMENDED BY THE REPEATED RESULT. THE PATIENT WAS STARTED ON NITROGLYCERIN DRIP DUE TO THE INITIAL ACCUTNI RESULT. THE DRIP WAS DISCONTINUED AFTER REPEAT TESTING PRODUCED A NORMAL RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other