BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142172 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01304
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 19, 2008
    Report Date
    December 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 AND PERFORMED A PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE DECONTAMINATED THE SUBSTRATE SYSTEM AND REPLACED THE SUBSTRATE SEALS AND THE O-RING. FSE RAN A SYSTEM CHECK AND IT PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALSO, ALL OTHER VERIFICATION TESTING PERFORMED BY THE FSE PASSED INSTRUMENT SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PATIENT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) ON (B)(6) 2008, REGARDING ERRONEOUS RESULTS ON TWO DIFFERENT PATIENTS FOR TROPONIN ASSAY. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THEY WERE WITHIN THE SPECIFIC RANGE. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGES TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Additional Manufacturer Narrative · 2

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 AND PERFORMED A PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE DECONTAMINATED THE SUBSTRATE SYSTEM AND REPLACED THE SUBSTRATE SEALS AND THE O-RING. FSE RAN A SYSTEM CHECK AND IT PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALSO, ALL OTHER VERIFICATION TESTING PERFORMED BY THE FSE PASSED INSTRUMENT SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PATIENT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO PATIENT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 2

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) ON (B)(6) 2008, REGARDING ERRONEOUS RESULTS ON TWO DIFFERENT PATIENTS FOR TROPONIN ASSAY. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THEY WERE WITHIN THE SPECIFIC RANGE. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGES TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ACCESS ACCUTNI
    2 58 YR