BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2490381 · Received March 13, 2012

    Report

    Report Number
    2122870-2012-00656
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    December 15, 2011
    Report Date
    February 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 AND (B)(6) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND NO SIGNIFICANT HARDWARE ISSUES, DID NOT REPLACE ANY INSTRUMENT PARTS, AND VERIFIED INSTRUMENT PERFORMANCE DURING BOTH SERVICE CALLS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-00656, 2122870-2012-00124, 2122870-2012-00503, 2122870-2012-00040, 2122870-2012-00657, 2122870-2012-00658, 2122870-2012-00659, 2122870-2012-00762, 2122870-2012-00763.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUPPLIED LABORATORY SUPPLIES TO BECKMAN COULTER INC. FOR INVESTIGATIVE TESTING PURPOSES. BECKMAN COULTER INC. INVESTIGATION CONDUCTED BY CUSTOMER PRODUCT LINE SUPPORT INDICATED THAT THE CAUSE OF THE ERRONEOUS PSA PATIENT RESULTS WAS SAMPLE CONTAMINATION, THROUGH THE USE OF TRANSFER PIPETTES WHICH HAD BEEN LIKELY CONTAMINATED WITH FREE PSA-CONTAINING AGENTS, SUCH AS A QUALITY CONTROL MATERIAL OR CALIBRATORS. THE PIPETTORS ARE NOT BECKMAN COULTER INC. MANUFACTURED PRODUCTS. THE MECHANISM OF THE TRANSFER PIPETTE CONTAMINATION IS UNKNOWN. BASED UPON THESE PREANALYTICAL FACTORS, IT WAS CONCLUDED THAT BECKMAN COULTER INC. DEVICE(S) WERE NOT A CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS, WITHIN AND ABOVE THE NORMAL REFERENCE RANGE, WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS ON MULTIPLE DAYS. THIS REPORT REPRESENTS THE HIGHER THAN EXPECTED PSA RESULT FOR ONE PATIENT GENERATED ON (B)(6) 2011. THE ELEVATED, INITIAL PSA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. BASED UPON THE ELEVATED, INITIAL PSA RESULT THE PATIENT UNDERWENT A BONE SCAN, WHICH WAS "NEGATIVE". THE PATIENT RECEIVED AN ONCOLOGY CONSULTATION, WAS ADMINISTERED CASODEX, AND LUPRON AND WAS SCHEDULED FOR A PSA RETEST IN FIVE WEEKS TIME. THE PSA RETEST GENERATED A LOWER PSA RESULT WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE CUSTOMER INDICATED THAT THE CHANGE IN INITIAL TO REPEAT RESULTS DID NOT MATCH THE EXPECTED PSA CLINICAL PROGRESSION OF PROSTATE DISEASE OR OF DISEASE TREATMENT PROTOCOLS. THE SAMPLE WAS COLLECTED IN A SERUM TUBE WITH GEL SEPARATOR AND ALLOWED TO CLOT FOR FIFTEEN MINUTES. THE SAMPLE WAS CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING. THERE WERE NO QUESTIONS WITH ANY OTHER ASSAYS. INSTRUMENT PSA QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATION DURING THE TIMEFRAME OF THIS EVENT. SPECIFIC PATIENT INFORMATION, RAW DATA RESULTS AND ADDITIONAL SYSTEM PERFORMANCE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESS HYBRITECH PSA REAGENT AND CALIBRATOR