BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2148032 · Received July 2, 2011

    Report

    Report Number
    2122870-2011-02067
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. BEC CUSTOMER TECHNICAL SUPPORT (CTS) DISCUSSED ISSUES RELATED TO ASSAY REAGENT PACKS BEING TRANSFERRED BETWEEN SYSTEMS PER THE RECALL Z-0607-2011. THE CUSTOMER STATED THAT THEY WILL RUN BHCG QC TO VERIFY THAT RESULTS ARE WITHIN SPECIFICATIONS AND REPEAT ANY BHCG SAMPLES THAT MAY HAVE BEEN RUN ON THE SHARED REAGENT PACK TO VERIFY REPRODUCIBILITY OF RESULTS. USER ERROR IS LIKELY THE ROOT CAUSE OF EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) OF OBTAINING A NO VALUE, IND (INDETERMINATE) FLAGGED BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE (1) PATIENT. THIS RESULT WAS NOT REPORTED OUT OF THE LAB. WHILE TROUBLESHOOTING WITH BEC HOTLINE, A BHCG REAGENT PACK WAS FOUND TO HAVE BEEN SHARED BETWEEN THE CUSTOMER'S TWO ACCESS SYSTEMS. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. 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 JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1