BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2132999 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01928
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS DRAWN IN THE ER AND WAS COLLECTED IN 13X 100 MM GREEN CAP PLASMA TUBES AND WAS CENTRIFUGED FOR 10 MINUTES AT 3000 RPM. THE SAMPLE WAS STORED AT ROOM TEMPERATURE PRIOR TO RUNNING THE REPEAT TESTING. PER THE CUSTOMER, QC IS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. PER CUSTOMER SUPPLIED DATA, SYSTEM CHECKS PERFORMED ON (B)(4) 2011, PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED THAT THE INCUBATOR BELT WAS RATTLING DURING OPERATION. THE FSE NOTED THAT THE INCUBATOR BELT WAS "STRETCHED" AND WAS MISSING A TOOTH. THE FSE REPLACED THE INCUBATOR BELT AND VESSEL HOLDERS. THE FSE ALSO OBSERVED A "VERY LARGE AMOUNT" OF WASH BUFFER BUILD UP IN THE WASH CAROUSEL. THE FSE CLEANED OUT THE CAROUSEL, REPLACED THE MIXER BELT AND MIXER PULLEYS, AND THEN VERIFIED INSTRUMENT ALIGNMENTS. THE FSE PERFORMED QC WITHIN THE CUSTOMER'S ESTABLISHED LIMITS TO VERIFY HARDWARE AFTER THE REPAIRS WERE COMPLETED. ALTHOUGH THE FSE COMPLETED SOME REPAIRS AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT THAT WAS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. REPEAT ANALYSIS OF THE SAMPLE PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR THE PATIENT. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1