BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1953327 · Received January 7, 2011

    Report

    Report Number
    2122870-2011-00022
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCUTNI SAMPLE WAS COLLECTED IN A LIHEP PLASMA TUBE. ALL REPEAT TESTING WAS PERFORMED AFTER THE ORIGINAL SAMPLE WAS RE-CENTRIFUGED. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE SAMPLE WAS SLIGHTLY LIPEMIC AND HAD A LAYER OF "HAZE" BETWEEN THE PLASMA AND CELLS. PER THE CUSTOMER SUPPLIED QC CHARTS, ALL FOUR LEVELS OF ACCUTNI QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE PAST 30 DAYS. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER ONLY WANTED THE ISSUE DOCUMENTED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUT-OFF FOR ONE PATIENT THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER SUBSEQUENT TESTING ON THE ORIGINAL INSTRUMENT, AN ALTERNATE INSTRUMENT, AND AN ALTERNATE METHODOLOGY PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE AND AN AMENDED REPORT WAS ISSUED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1