BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1061499 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00189
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 17, 2008
    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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC LEVEL I WAS OUT HIGH IN 2008 BEFORE THE EVENT AND PASSED UPON REPEAT. QC LEVEL III WAS WITHIN SPECIFICATIONS. NO OTHER RESULTS OF ASSAYS WERE QUESTIONED BY THE CUSTOMER. THE LAB POLICY IS TO REPEAT ALL POSITIVE ACCU TNI SAMPLES BEFORE REPORTING THEM OUT OF THE LAB. THE SPECIMEN WAS COLLECTED IN A BD, LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED PER THE MANUFACTURE'S RECOMMENDATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE CHECKED ALL INTERNAL SYSTEMS AND ALIGNMENTS. THE FSE REPLACED A TRANSDUCER AND ASPIRATE PROBES. THE FSE PERFORMED HARDWARE VERIFICATION PROTOCOL ALONG WITH 50-REPLICATES ACCU TNI RUN. ALL VERIFICATION TESTING PASSED WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PATIENT. A PATIENT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 1.29NG/ML WAS REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RETESTED ON THE NEXT DAY AND REPEATED RESULT WAS 0.03 NG/ML. A CORRECTED REPORT WAS SUBMITTED. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT OCCURED AS A RESULT OF 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 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA