BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001877 · Received February 25, 2011

    Report

    Report Number
    2122870-2011-00500
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS ASPIRED FROM THE PRIMARY COLLECTION TUBE FOR THE INITIAL RESULT. FOR THE REPEAT TESTING THE SAMPLE WAS ASPIRED FROM AN INSERT CUP. NO SAMPLE QUALITY ISSUE WAS NOTED. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. A SYSTEM CHECK WAS PERFORMED PRIOR TO THE EVENT AND THE RESULTS BARELY MET THE SPECIFICATIONS OF THE WASHED %CV, AT 11.18%. THE CUSTOMER PUT ON A DIFFERENT CLEAN SET OF ASPIRATE PROBES AND REPEATED THE SYSTEM CHECK. ALL RESULTS MET THE SPECIFICATIONS WITH THE WASHED %CV AT 5.82%. NO ERROR WAS POSTED TO THE EVENT LOG. SERVICE WAS ON SITE ON (B)(6) 2011 AND PERFORMED A PREVENTIVE MAINTENANCE. NO HARDWARE ISSUE WAS NOTED. NO DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO AN ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. REPEAT ANALYSIS ON THE SAME INSTRUMENT PRODUCED RESULTS WITHIN THE RISK STRATIFICATION RAGE. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING BY AN ALTERNATE METHOD PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THERE WAS NO REPORT OF DEATH, INJURY, 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1