BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1438299 · Received August 13, 2009

    Report

    Report Number
    2122870-2009-00272
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    July 29, 2009
    Report Date
    August 13, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITHOUT GEL. THE SAMPLE WAS INITIALLY SPUN AT 3,500 RPM FOR 8 MINUTES. THE SAMPLE WAS A FULL DRAW WITH NO VISIBLE FIBRIN. ALL TESTING WAS PERFORMED FROM THE PRIMARY TUBE. THE LAST SYSTEM CHECK PERFORMED ON 06/06/2009 WAS WITHIN SPECIFICATIONS. PER CUSTOMER'S QC CHARTS, NO QC ISSUES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED DIAGNOSTIC AND CARRYOVER TESTING; ALL RESULTS RECOVERED WITHIN SPECIFICATIONS. THE FSE PRO-ACTIVELY REPLACED THE SAMPLE PIPETTOR. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT, ABOVE THE AMI CUT-OFF, FOR ONE PATIENT. THE INITIAL RESULT WAS 0.73NG/ML. THE ORIGINAL SAMPLE WAS RE-CENTRIFUGED AND REPEATED, RECOVERING RESULT OD 0.14NG/ML. THE RESULTS WERE REPORTED OUT OF THE LAB. 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 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1