BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1943257 · Received December 31, 2010

    Report

    Report Number
    2122870-2010-01000
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 12 X 75 MM BD LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE AND WAS A FULL DRAW WITH NO VISUAL SIGN OF FIBRIN. QC IS PERFORMED EVERY 12 HOURS, AND WAS WITHIN THE ESTABLISHED RANGES. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND THE RESULTS MET THE SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2010. THE FSE DISCOVERED BUBBLES IN THE WASH PUMP, AND REPLACED SOME HARDWARE COMPONENTS INCLUDING THE WASH PUMP SEALS. THE FSE PRIMED THE SYSTEM AND PERFORMED A HIGH SENSITIVITY SYSTEM CHECK. NO ISSUE WAS NOTED. THE FSE THEN NOTICED AN AIR SLUG FORMING IN THE WASH PUMP, AND REPLACED THE WASH VALVE ROTOR AND THE PRECISION PUMP STATOR. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A PRECISION TEST. ALL TESTING MET THE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. THE PATIENTS WERE ADMITTED TO THE HOSPITAL FOR OBSERVATION DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other