BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2232149 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03099
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 22, 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
    AL, 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) COMPLETED AN INSTRUMENT ULTRASONIC MODIFICATION AND ADDITIONAL PREVENTIVE MAINTENANCE ACTIVITIES. THE FSE REPLACED THE WASH VALVE ROTOR AND PRECISION BELT. THE FSE ADDRESSED SIGNIFICANT WASH BUFFER BUILDUP ON THE WASH AND PRECISION VALVES. THE FSE PERFORMED AN INSTRUMENT SYSTEM CHECK WHICH GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS. INSTRUMENT ASSAY QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE INSTRUMENT WAS RETURNED TO SERVICE AFTER THE COMPLETION OF THE NECESSARY VERIFIED REPAIRS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03098, 2122870-2011-03099.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS, ELEVATED FREE THYROXINE (FT4) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES ON DIFFERENT DAYS. THIS REPORT IS TWO OF TWO AND REPRESENTS THE INITIAL, ELEVATED FREE THYROXINE (FT4) RESULT, ABOVE THE NORMAL REFERENCE RANGE, WHICH WAS GENERATED FOR ONE PATIENT AT AN UNKNOWN DATE. FOR THE PURPOSES OF THIS REPORT THE EVENT DATE IS INFERRED TO BE (B)(6) 2011. REPEAT TESTING OF THE PATIENT SAMPLE ON THE SAME INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE ACTUAL REPEAT PATIENT RESULT WAS NOT PROVIDED BY THE CUSTOMER. THE INITIAL FT4 RESULT WAS REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. PATIENT SPECIFIC INFORMATION, INSTRUMENT SYSTEM INFORMATION AND SAMPLE HANDLING/COLLECTION INFORMATION WERE 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 FREE T4 REAGENT