BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2179235 · Received July 26, 2011

    Report

    Report Number
    2122870-2011-02511
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN BD LIHEP PLASMA TUBES AND CENTRIFUGED FOR 10 MINUTES AT 3000 RPM IN A SWINGING BUCKET CENTRIFUGE. PER THE CUSTOMER, QC WAS NOT PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS AT THE TIME OF THE EVENT. CUSTOMER'S SUPPLIED DATA SHOW THAT SYSTEM CHECKS PERFORMED ON (B)(4) 2011, PASSED WITHIN INSTRUMENT SPECIFICATIONS. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE REPLACED THE INCUBATOR BELT, RV CLIPS AND THE PIPETTOR TIP. THE FSE VERIFIED HARDWARE PERFORMANCE BY COMPLETING A HIGH SENSITIVITY SYSTEM CHECK AND A SYSTEM CHECK THAT PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE ALSO COMPLETED A PRECISION RUN AND QC WAS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. ALTHOUGH THE FSE COMPLETED SOME HARDWARE REPAIRS, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110410) AND ACCESS ACCUTNI CALIBRATORS (LOT 023153). THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. REPEAT ANALYSIS OF THE PATIENT'S SAMPLE ON THE SAME INSTRUMENT PRODUCED SIMILAR RESULTS WITHIN THE RISK STRATIFICATION RANGE WHILE REPEAT ANALYSIS ON AN ALTERNATE METHOD PRODUCED "NEGATIVE" RESULTS. RESULTS ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1