BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1911162 · Received November 30, 2010

    Report

    Report Number
    2122870-2010-00800
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH FAILED, BUT UPON REPEAT WAS WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED A PRECISION TEST AFTER THE EVENT WHICH FAILED WITH A FEW FLIERS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 FOR THIS EVENT. THE FSE PERFORMED A PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE ALSO PERFORMED A ROUTINE SYSTEM CHECK WHICH FAILED. THE FSE REPLACED THE SUBSTRATE VALVE AND RAN ANOTHER ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED AN ACCUTNI PRECISION TEST WHICH PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE DEFINITIVE ROOT CAUSE COULD NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULT ABOVE THE AMI CUT-OFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY, BUT WAS AMENDED. 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1