BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172506 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02381
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT BECAUSE THE ISSUE WAS SUCCESSFULLY ADDRESSED VIA BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SERVICE (CTS) TROUBLESHOOTING AND SITE BIOMEDICAL ENGINEERING SUPPORT. THE CUSTOMER PERFORMED AN INSTRUMENT SYSTEM CHECK AFTER THE EVENT. THE ASSESSMENT FAILED DUE TO ELEVATED WASHED MEAN AND %CV (COEFFICIENT OF VARIATION). BCI CTS RECOMMENDED THAT THE CUSTOMER REPLACE THE ASPIRATE PROBE AND REPEAT THE INSTRUMENT SYSTEM CHECK. THE CUSTOMER NOTICED THAT THE ASPIRATE #2 PROBE WAS DISCONNECTED AND CORRECTED THE PROBLEM. A SECOND INSTRUMENT CHECK WAS PERFORMED WHICH FAILED DUE TO ELEVATED SUBSTRATE MEAN. ADDITIONALLY THE INSTRUMENT GENERATED DARK COUNT OUTSIDE LIMIT ERRORS. THE PROBABLE CAUSE WAS IDENTIFIED AS A CONTAMINATED SUBSTRATE SYSTEM. THE SUBSTRATE SYSTEM WAS DECONTAMINATED BY CUSTOMER PERSONNEL AND A CONFIRMATORY SYSTEM CHECK AND ACCUTNI INSTRUMENT QUALITY CONTROL ASSESSMENT WERE EXECUTED WITH ACCEPTABLE RESULTS. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-02370, 2122870-2011-02371, 2122870-2011-02372, 2122870-2011-02373, 2122870-2011-02374, 2122870-2011-02375, 2122870-2011-02376, 2122870-2011-02377, 2122870-2011-02378, 2122870-2011-02379, AND 2122870-2011-02380.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS, ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD OR WITHIN THE RISK STRATIFICATION RANGE, WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. THIS REPORT REPRESENTS THE RESULTS ASSOCIATED WITH PATIENT TWELVE OF TWELVE WHOSE INITIAL ACCUTNI RESULT WAS ELEVATED AND WITHIN THE RISK STRATIFICATION RANGE. THE ACCUTNI TEST WAS REPEATED ON ANOTHER INSTRUMENT. THE REPEAT RESULT WAS LOWER AND WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL, ERRONEOUS ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT SOME OF THE PATIENTS INVOLVED IN THIS EVENT WERE HOSPITALIZED BASED UPON THE ELEVATED ACCUTNI RESULTS. IT IS UNKNOWN WHICH PATIENTS WERE HOSPITALIZED. FOR THE PURPOSE OF THIS REPORT IT IS ASSUMED THAT ALL PATIENTS INVOLVED IN THIS EVENT WERE ADMITTED TO THE HOSPITAL BASED UPON THEIR ACCUTNI INITIAL RESULTS. INSTRUMENT ACCUTNI QUALITY CONTROL (QC) RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES PRIOR TO THE EVENT, HOWEVER AFTER THE EVENT ALL LEVELS OF QC WERE ELEVATED OUTSIDE OF THE CUSTOMER ESTABLISHED RANGE. NO SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    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 Hospitalization| R ACCESS ACCUTNI - REAGENT