BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1914430 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00848
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASMA TUBE WITH A GEL SEPARATOR. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE PRE AND POST THE EVENT. THE CUSTOMER PERFORMED SYSTEM CHECK, WHICH FAILED THE UNWASHED SPECIFICATION. SERVICE AS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER HAS AN ON-SITE BIOMEDICAL ENGINEER (BME) WHO PERFORMED THE FOLLOWINGS: A. NOTED THE TUBE LEADING TO THE WASH TOWER WAS INTERMITTENTLY COLLAPSING WHICH AFFECTED THE AMOUNT OF FLUID USED TO WASH THE MAIN PIPETTOR. BME TRIMMED THE TUBE. B. PERFORMED ROUTINE SYSTEM CHECK WHICH PASSED INSTRUMENT SPECIFICATIONS HARDWARE IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS ELEVATED ACCUTNL RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLE WAS RETESTED ON THE SAME UNIT AND AN ALTERNATE UNIT AND BOTH GENERATED LOWER RESULTS. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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