BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2128429 · Received June 16, 2011

    Report

    Report Number
    2122870-2011-01808
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUS "NO VALUE" RESULTS FOR PROSTRATE-SPECIFIC ANTIGEN (PSA) FOR NINE PATIENT SAMPLES ASSAYED USING THE ACCESS HYBRITECH PSA REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS WERE WITHIN ESTABLISHED RANGES PRIOR TO THE "NO VALUE" RESULTS GENERATED FOR THE NINE PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE PERFORMED A PREVENTIVE MAINTENANCE ON THE ANALYZER. NO HARDWARE ISSUES WERE OBSERVED. ALL VERIFICATION TESTING MET SPECIFICATIONS. THE CUSTOMER REPEATED THE PSA ASSAYS FOR THE NINE PATIENT SAMPLES AFTER THE FSE PERFORMED THE PREVENTIVE MAINTENANCE. ALL NINE PATIENT SAMPLES YIELDED NUMERICAL RESULTS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYBRITECH PSA REAGENT