BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1974038 · Received January 31, 2011

    Report

    Report Number
    2122870-2011-00161
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO OBTAINED 0.0 NG/ML RESULTS FOR ALL LEVELS OF ACCUTNI ON THE DAY OF THE EVENT. THE CUSTOMER PERFORMED A ROUTING SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (CTS) AND DISCOVERED THAT THE IN USE ACCUTNI REAGENT PACK HAD ALSO BEEN LOADED ON THE CUSTOMER'S OTHER ACCESS 2 PREVIOUSLY. THEREFORE IT WAS VERIFIED THAT THE PACK WAS SHARED BETWEEN THE CUSTOMER'S TWO INSTRUMENTS. WHEN THIS OCCURS THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ROOT CAUSE WAS DISCOVERED WHILE TROUBLESHOOTING WITH CTS AS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULTS IN THE NORMAL REFERENCE RANGE FOR TWO PATIENTS AND WITHIN THE RISK STRATIFICATION RANGE FOR TWO ADDITIONAL PATIENTS THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS WITHIN THE RISK STRATIFICATION FOR THE NORMAL PATIENTS AND ABOVE THE AMI CUT-OFF FOR THE RISK STRATIFICATION PATIENTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTE OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1