BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2152336 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01940
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER DID NOT EVALUATE THE DEVICE. THE BCI CUSTOMER TECHNICAL SUPPORT CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER AND IT WAS DISCOVERED THAT THE CUSTOMER HAD MISLOADED THE REAGENT PACK ON THE SYSTEM. THE ACCUTNI REAGENT PACK WAS NOT IN THE APPROPRIATE SLOT IN THE REAGENT CAROUSEL. A CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS IS TWO OF TWO SEPARATE MDR REPORTS RELATED TO TWO PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01939, 01940 FOR ALL EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY LOW ACCUTNI (TROPONIN 1) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE INITIAL ERRONEOUSLY LOW RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLE TESTING FOR THE TWO PATIENTS IN ANOTHER FACILITY AND THE CORRECTED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI