BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2144890 · Received June 30, 2011

    Report

    Report Number
    2122870-2011-02063
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 31, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT QC WAS PERFORMING WITHIN INSTRUMENT SPECIFICATIONS PRIOR TO THE EVENT. CUSTOMER HAS NOT SUPPLIED SYSTEM CHECK DATA TO DATE. A REVIEW OF CUSTOMER'S ARCHIVE DATA FROM THE CUSTOMER'S ACCESS 2 AND ACCESS 2I SHOWS THAT THE CORTISOL PACK (B)(4) HAD BEEN USED TO GENERATE A CALIBRATION CURVE ON THE ACCESS 2I, AND TO GENERATE QC AND PROFICIENCY SURVEY RESULTS ON THE ACCESS 2 INSTRUMENT. PER LABELING, INSTRUCTIONS FOR LOADING A REAGENT PACK STATES WARNING, "IF A PARTIALLY USED REAGENT PACK IS LOADED ON A DIFFERENT SYSTEM OR WORKGROUP, IT WILL BE INVENTORIED AS A FULL PACK AND INACCURATE RESULTS MAY OCCUR." USER ERROR IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) HOTLINE A CORTISOL PROFICIENCY SURVEY FAILURE ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER ALSO REPORTED THAT THEY HAD FAILED TWO CORTISOL CALIBRATION CURVES SUBSEQUENT TO THE PROFICIENCY SURVEY FAILURE. WHILE TROUBLESHOOTING, HOTLINE DISCOVERED THAT THE CORTISOL REAGENT PACK USED TO GENERATE THE PROFICIENCY SURVEY RESULTS HAD BEEN SHARED BETWEEN THE CUSTOMER'S ACCESS 2 AND ACCESS 2I INSTRUMENTS. WHEN THE REAGENT PACK IS SHARED BETWEEN 2 INSTRUMENTS, THE INSTRUMENT DOES NOT DETECT EITHER A WRONG REAGENT PACK OR THAT NO REAGENT PACK IS PRESENT. NO PATIENT RESULTS WERE OBTAINED FROM THE SHARED REAGENT PACK. 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 ANALYZER CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1