BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTNI

    MDR report key: 1723077 · Received June 8, 2010

    Report

    Report Number
    MW5016286
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 8, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    MMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BECKMAN COULTER ACCESS 2 SYSTEM REPORTED FALSE NEGATIVE TROPONIN RESULTS -0.00 NG/ML - ON SIX PATIENTS THAT WERE LATER REPEATED AND RESULTED ABOVE THE AMI CUTOFF >0.50 NG/ML. IT WAS DETERMINED THAT THE ROOT CAUSE WAS DUE TO NO PACK PRESENT ON THE SYSTEM. ALL ACCESS PLATFORM SYSTEMS HAVE A DESIGN FLAW THAT DOES NOT ALERT THE USER TO WHEN NO PACK OR THE WRONG PACK IS BEING USED FOR PT TESTING. IT ALSO ALLOWS THE USER TO LOAD A PACK THAT HAS BEEN IN USE ON ANOTHER SYSTEM AND THEREFORE THE TEST COUNT IS NOT CORRECT. THIS TOO WILL CAUSE ERRONEOUS BUT BELIEVABLE RESULTS WITH NO RELIABLE ALERTS TO THE USERS. THIS HAS BEEN BRUSHED UNDER THE RUG AND DETERMINED A CUSTOMER ERROR, THEREFORE, IT IS NOT THE RESPONSIBILITY OF BECKMAN COULTER TO FIX. THESE EVENTS HAVE NOT BEEN REPORTED TO THE FDA DUE TO THIS MIND SET. PLEASE MAKE THEM DO SOMETHING TO FIX THIS. IT HAS ALSO OCCURRED AS FALSE NEGATIVE BHCG, PSA, AFP AND MORE. THIS IS EVEN BIGGER THAN PLATFORM BIAS FOR ACCUTNI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTNI TROPONIN MMI BECKMAN COULTER INC ACCESS 2 ALL
    2 BHCG TOTAL BHCG JHI BECKMAN COULTER INC. ACCESS 2 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O