BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2446776 · Received February 10, 2012

    Report

    Report Number
    2122870-2012-00303
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CDZ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 INCUBATOR BELT AND REACTION VESSEL CLIPS. THE FSE ALSO REPLACED THE PIPETTOR TIP TO ADDRESS THE INSTRUMENT POSTED ULTRASONIC ERRORS. THE FSE PERFORMED SYSTEM CHECKS WHICH GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS TO VERIFY INSTRUMENT HARDWARE AFTER REPAIRS WERE COMPLETED. THE INSTRUMENT WAS RETURNED BACK INTO OPERATION AFTER THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS. THE CAUSE FOR THIS EVENT IS UNKNOWN AND COULD NOT BE DETERMINED BASED ON THE SUPPLIED INFORMATION. ASSOCIATED MDRS: 2122870-2012-00302, 2122870-2012-00323, 2122870-2012-00303, 2122870-2012-00322, 2122870-2012-00360.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS TESTOSTERONE AND HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB-PSA) RESULTS WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS ACROSS MULTIPLE DAYS. THIS REPORT REPRESENTS THE INITIAL, HIGHER THAN EXPECTED TESTOSTERONE RESULT GENERATED ON (B)(6) 2012 FOR ONE PATIENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT REPEAT TESTING OF THE PATIENT SAMPLE PRODUCED A LOWER RESULT BELOW THE NORMAL REFERENCE RANGE OF THE ASSAY. THE CUSTOMER PROVIDED ADDITIONAL PATIENT DATA HOWEVER OTHER PATIENT/ASSAY RESULTS WERE NOT QUESTIONED AS PART OF THIS EVENT. THE INITIAL, HIGHER TESTOSTERONE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT ASSAY QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS. THE CUSTOMER REPORTED THEY OBSERVED ULTRASONIC ERRORS IN THE INSTRUMENT EVENT LOG ON THE DATE OF THE EVENT. MAINTENANCE WAS CURRENT ON THE INSTRUMENT AT THE TIME OF THE EVENT. SAMPLES WERE COLLECTED AT, AND RECEIVED FROM, ANY ONE OF SEVEN OUTSIDE FACILITIES. THE SAMPLES WERE COLLECTED VIA VENIPUNCTURE INTO PLASTIC COLLECTION TUBES WITH GEL SEPARATORS. THE SAMPLES WERE NORMAL IN APPEARANCE. SPECIFIC PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TESTOSTERONE REAGENT