BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2241370 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03094
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER WAS ADVISED BY BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES TO RECALIBRATE THE ASSAY AND REPEAT PATIENT SAMPLES. THE S0 CALIBRATOR GENERATED RLUS WHICH WERE SIMILAR TO RELEASED DATA. PATIENT REPEAT RESULTS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE FOR THE ELEVATED S0 RLUS HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 NO-VALUE FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) RESULTS WITH INDETERMINATE SYSTEM FLAGS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE PATIENT SAMPLES. PATIENT REPEAT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. AN INDETERMINATE SYSTEM FLAG IS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE BECAUSE OF RELATIVE LIGHT UNIT (RLU) ISSUES. THE INITIAL NO-VALUE FREE PSA RESULTS WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THROUGH TROUBLESHOOTING WITH BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES, IT WAS DETERMINED THAT THE ASSAY'S S0 CALIBRATORS RLUS WERE ELEVATED AND APPROXIMATELY TWICE THAT OF CUSTOMER FREE PSA QUALITY CONTROL RESULTS. AN INSTRUMENT CHECK PERFORMED PRIOR TO THE EVENT MET ESTABLISHED SPECIFICATIONS. PATIENT SPECIFIC INFORMATION AND SAMPLE HANDLING/COLLECTION 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYBRITECH FREE PSA REAGENT