BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230318 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03366
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS INSTRUMENT HARDWARE PERFORMANCE WAS NOT QUESTIONED. NO ROOT CAUSE WAS DETERMINED FOR THE ELEVATED S0 RLUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 CARDIAC TROPONIN (ACCUTNI) NO VALUE RESULTS WITH INSTRUMENT GENERATED FLAGS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR SIX PATIENT SAMPLES. THE INSTRUMENT FLAG WAS AN INDETERMINATE FLAG WHICH IS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE. THE PATIENT SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND REPEAT ACCUTNI RESULTS WERE GENERATED WHICH WERE LOWER. THE ACTUAL REPEAT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. CUSTOMER TROUBLESHOOTING INDICATED THAT THE ACCUTNI NO VALUE RESULTS WITH INSTRUMENT GENERATED FLAGS WERE CAUSED BY S0 CALIBRATOR RLUS WHICH WERE HIGHER THAN CUSTOMER ESTABLISHED QUALITY CONTROL RELEASE DATA. THE INITIAL ACCUTNI NO VALUE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SPECIFIC PATIENT INFORMATION, SAMPLE HANDLING/COLLECTION AND SYSTEM INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. AN INSTRUMENT SYSTEM CHECK AND CALIBRATION PERFORMED PRIOR TO THE EVENT GENERATED ACCEPTABLE RESULTS. THE CUSTOMER INDICATED THAT LOW LEVEL ACCUTNI QC HAD BEEN ON THE LOW SIDE OF THE MEAN AND HAD BEEN OUT OF LOWER SPECIFICATION AT TIMES SINCE INSTRUMENT CALIBRATION.

    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