BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2121795 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01130
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    June 17, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SYSTEMS CHECK DATA WAS SUPPLIED. PER THE DIAGNOSTIC COPY TO DISK FILE SUPPLIED BY THE CUSTOMER, THREE LEVELS OF THYROID-STIMULATING HORMONE (TSH) QC WERE TESTED TWICE DAILY WITH A FOURTH ULTRA LOW LEVEL TESTED ONCE DAILY. SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS IDENTIFIED DURING THE INITIAL TROUBLESHOOTING VIA THE TELEPHONE. IT WAS DETERMINED THAT PACK SHARING OCCURRED RESULTING IN ERRONEOUS RESULTS DUE TO OPERATOR ERROR. AS INDICATED IN THE LABELING, 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. THE CUSTOMER ACKNOWLEDGED AND RE-EDUCATED THE OPERATORS THAT PACK SHARING IS NOT ALLOWED ON THE ACCESS PLATFORMS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH IS RELATED TO THE ORIGINAL MDR 2122870-2010-00318, PATIENT NUMBER ONE. RELATED MDR: 2122870-2011-01129.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED RECEIVING INDETERMINATE (IND) RESULTS/NO VALUE FLAGS ON THE THYROID-STIMULATING HORMONE (TSH) ON QUALITY CONTROL (QC) SAMPLES GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. IT WAS DISCOVERED THAT A TSH REAGENT PACK HAD BEEN REMOVED FROM THE SYSTEM INCORRECTLY. THREE PATIENTS' SAMPLES HAD ALSO BEEN TESTED FROM THE SAME REAGENT PACK. THIS REPORT REFERS TO PATIENT NUMBER THREE. THE CUSTOMER RETESTED THE THREE PATIENTS' SAMPLES AND PRODUCED THE SAME RESULTS. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY OR WHETHER A CHANGE IN PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS HYPERSENSITIVE HTSH