BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2484412 · Received March 8, 2012

    Report

    Report Number
    2122870-2012-00608
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ANALYTICAL UNIT HARD DRIVE, A CENTRAL PROCESSING UNIT BOARD, AND THE NETWORK INTERFACE CARD. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. THE FSE NOTED THAT A "BAD PARTITION" ON THE ANALYTICAL UNIT HARD DRIVE CREATED THE ISSUE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-00608, 2122870-2012-00646, 2122870-2012-00645.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCREPANT OR IMPRECISE CARDIAC TROPONIN (ACCUTNI), PROSTATE SPECIFIC ANTIGEN OR THYROID STIMULATING HORMONE RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. THIS REPORT REPRESENTS THE IMPRECISE OR DISCREPANT ACCUTNI RESULTS GENERATED FOR FOUR PATIENTS ON (B)(6) 2012. THE CUSTOMER REPORTED ONE DISCREPANT ACCUTNI RESULT INITIALLY, HOWEVER BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER PROVIDED INFORMATION INDICATED THAT ERRONEOUSLY ELEVATED ACCUTNI RESULTS (ABOVE THE NORMAL RANGE OF THE ASSAY) WERE GENERATED FOR THREE PATIENTS, AND IMPRECISE ACCUTNI RESULTS WERE GENERATED FOR A FOURTH PATIENT. UPON REPEAT ON THE SAME INSTRUMENT THE DISCREPANT PATIENT RESULTS RECOVERED LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, AND WERE CONSIDERED VALID. FOR THE FOURTH PATIENT, THE INITIAL RESULT WAS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. UPON REPEAT ON THE SAME INSTRUMENT THE RESULT WAS LOWER, WITHIN THE NORMAL REFERENCE RANGE, AND COLLECTIVELY DID NOT MEET THE PRECISION CLAIMS OF THE ASSAY. WHILE THE SUSPECT ACCUTNI RESULTS WERE REPORTED OUT OF THE LABORATORY THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. ONE PATIENT'S INITIAL ACCUTNI RESULT WAS QUESTIONED BY A PHYSICIAN AND MANDATED RETESTING WHICH IDENTIFIED IT AS ERRONEOUS. INSTRUMENT ASSAY QUALITY CONTROL RESULTS FAILED TO RECOVER WITHIN THE CUSTOMER'S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. IDLE TIMER EXPIRED ERRORS, SAMPLE COUNTS OUTSIDE LIMITS ERRORS, AND STATUS CONTROLLER INITIALIZATION ERRORS HAD BEEN RE-OCCURRING FOR SEVERAL DAYS LEADING UP TO THE EVENT DATE. PATIENT SPECIFIC INFORMATION AND SAMPLE COLLECTION/HANDLING 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI REAGENT