BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2242260 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03574
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS INSTRUMENT PERFORMANCE WAS NOT QUESTIONED. BECKMAN COULTER INC. ASSESSMENT OF INSTRUMENT GENERATED DATA AND SUPPLIED TROUBLESHOOTING ASSISTED THE CUSTOMER IN RESOLVING THE ISSUE. NO ROOT CAUSE WAS DETERMINED FOR THE ELEVATED S0 RLUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, ERRATIC CARDIAC TROPONIN (ACCUTNI) QUALITY CONTROL (QC) RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING INDICATED THAT THE ERRATIC ACCUTNI QC RESULTS WERE CAUSED BY S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) WHICH WERE HIGHER THAN CUSTOMER ESTABLISHED QUALITY CONTROL RELEASE DATA. WHILE IT IS UNCERTAIN AS TO WHETHER PATIENT RESULTS WERE AFFECTED IN CONNECTION TO THE EVENT, THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. UPON RECALIBRATION USING THE SAME CALIBRATOR AND REAGENT LOT, THE CUSTOMER WAS ABLE TO LOWER THE S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) AND GENERATE QUALITY CONTROL RESULTS WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. NO SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER. PER BECKMAN COULTER ASSESSMENT OF CUSTOMER SUPPLIED DATA, AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT GENERATED ACCEPTABLE RESULTS.

    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 ACCUTNI - REAGENT