BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172346 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02367
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) HAD THE CUSTOMER PERFORM A ROUTINE SYSTEM CHECK AND A 50 REPLICATE PRECISION TEST. BOTH PERFORMANCE ASSESSMENTS GENERATED ACCEPTABLE RESULTS. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED AN INSTRUMENT ADJUSTMENT INVOLVING "ULTRASONICS - ADJUST TO FIXED 197 VOLTAGE." ALTHOUGH MODIFICATIONS WERE MADE TO THE INSTRUMENT BEFORE RETURNING IT INTO SERVICE A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS FOR THIS EVENT: 2122870-2011-02394, 2122870-2011-02366, 2122870-2011-02367.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMPRECISE PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENT SAMPLES ON MULTIPLE DAYS. DATA PROVIDED BY THE CUSTOMER INDICATES THAT FOR TWO PATIENTS, IMPRECISE PSA RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM ON MULTIPLE DAYS. THIS REPORT REPRESENTS THE IMPRECISE RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM ON (B)(6) 2011 FOR PATIENT TWO. THE RESULT, WHICH WAS HIGHER THAN EXPECTED BUT WITHIN THE NORMAL REFERENCE RANGE, WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE SAME SAMPLE WAS REPEATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. IT GENERATED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. ALTHOUGH IMPRECISE PSA RESULTS WERE RELEASED FROM THE LABORATORY, THERE WERE NO REPORTED DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENTS' TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BOTH LEVELS OF PSA QUALITY CONTROL (QC) WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA WAS NOT SUPPLIED TO DATE. THE CUSTOMER NOTED THAT WERE NO ISSUES REGARDING INSTRUMENT SYSTEM CHECKS, EVENT LOG ERROR MESSAGES OR OTHER ASSAYS TO DATE. THE SAMPLE WAS COLLECTED IN A SERUM TUBE WITH A GEL SEPARATOR, AND WAS CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING. THE CUSTOMER TRANSFERS AND ANALYZES REPEAT SAMPLES FROM SECONDARY TUBES.

    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 PSA REAGENT