BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2942752 · Received February 4, 2013

    Report

    Report Number
    2122870-2013-00076
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LITHIUM HEPARIN COLLECTED INTO EITHER 3 OR 7ML TUBES WITH SEPARATORS. THE SAMPLES ARE CENTRIFUGED FOR 10 MINUTES AT 3000RPMS. THE SAMPLES IN QUESTION ARE RUN FROM AN INSERT CUP PLACED INTO A PRIMARY TUBE. ALL SAMPLES ARE FILTERED. THE SAMPLES WERE FULL DRAWS AND ARE NORMAL IN APPEARANCE. BEC CUSTOMER TECHNICAL SUPPORT (CTS) REQUESTED THE CUSTOMER RUN A SYSTEM CHECK AND PRECISION. THE PRECISION RUN DEMONSTRATED ACCEPTABLE PRECISION AND THE SYSTEM CHECK RECOVERED IN RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON THE MORNING OF (B)(4) 2013 AND PERFORMED MULTIPLE DIAGNOSTIC ASSAYS, ALL OF WHICH PASSED. NO FAULT WAS FOUND WITH THE INSTRUMENT AT THIS TIME. THE CUSTOMER CONTACTED CTS AGAIN ON (B)(4) 2013 (LATER THAT DAY) TO REPORT THREE ADDITIONAL FALSE ACCUTNI PATIENT RESULTS. THIS IS DOCUMENTED IN MDR 2122870-2013-00080. THE CUSTOMER PERFORMED A PRECISION RUN, WHICH FAILED AT THIS TIME. THE FSE RETURNED TO THE CUSTOMER SITE ON (B)(4) 2013 AND NOTED THAT THE BOTTOM END OF THE MAIN PIPETTOR TIP 'FELT ROUGH'. THE FSE REPLACED THE MAIN PIPETTOR TIP, WHICH WAS BELIEVED TO BE THE CAUSE OF THE ERRONEOUS RESULTS. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS REPORT: 2122870-2013-00073, 2122870-2013-00080.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING MULTIPLE ERRONEOUS TROPONIN (ACCUTNI) PATIENT RESULTS THAT DID NOT RECOVER AS EXPECTED GENERATED ON THE ACCESS 2 IMMUNOASSAY ANALYZER OVER THE COURSE OF THREE (3) DIFFERENT OPERATIONAL SHIFTS. THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON THE SECOND SHIFT ON (B)(6) 2013. SOME RESULTS ON THIS INSTRUMENT WERE RECOVERING ERRONEOUSLY HIGHER AND OTHERS WERE ERRONEOUSLY LOWER THAN THE RESULTS GENERATED ON THE CUSTOMER'S ALTERNATE INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) SHOWED THAT ALL LEVELS OF QC HAVE BEEN WITHIN RANGE. A RECENT SYSTEM CHECK PASSED ALL MEASURED PARAMETERS. CALIBRATIONS HAVE BEEN SUCCESSFUL. THERE WAS NOT CHANGE TO, OR IMPACT ON, PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46083 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1