BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1934866 · Received December 21, 2010

    Report

    Report Number
    2122870-2010-00928
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS LITHIUM HEPARIN WITH A GEL BARRIER THAT WAS CENTRIFUGED FOR 5 MINUTES AT 4,500G. SPECIMEN APPEARANCE WAS NORMAL AND WAS ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND ONE PORTION FAILED. THE CUSTOMER REPEATED THE SYSTEM CHECK THAT SAME DAY AND IT MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, WHICH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBTAINING A FALSELY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, AND A CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE SPECIMEN WAS RE-CENTRIFUGED AND REPEATED ON A DIFFERENT INSTRUMENT WHICH RESULTED IN THE NORMAL REFERENCE RANGES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB 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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR