BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 1920269 · Received December 10, 2010

    Report

    Report Number
    2122870-2010-00877
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS LI HEPARIN COLLECTED IN A PST TUBE. THE SAMPLE WAS EITHER CENTRIFUGED FOR 6 MINUTES AT 3800RPM OR 3 MINUTES AT 5100RPM. ALL TESTING WAS FROM THE PRIMARY COLLECTION TUBE VIA THE CLOSED TUBE ACCESSING (CTA) SYSTEM. CUSTOMER STATED THAT THE SAMPLE APPEARANCE WAS NORMAL. QC PERFORMED AFTER THE ERRONEOUS RESULT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 AND PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK AND A PRECISION RUN, WHICH MET SPECIFICATIONS. THE FSE DID NOT NOTE ANY ISSUES WITH THE CUSTOMER'S QC OR MAINTENANCE RECORDS. THE FSE NOTED THAT THE CUSTOMER HAD STARTED USING A DIFFERENT CENTRIFUGE IN THE LAST MONTH AND RECOMMENDED THE CUSTOMER TO RETURN TO USING THE LARGER CENTRIFUGE THAT SPINS FOR 6 MINUTES AT 3800RPM. NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ACCUTNI (TROPONIN) RESULTS ABOVE THE AMI CUTOFF FOR ONE PATIENT SAMPLE THAT WAS GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. REPEAT TESTING WAS PERFORMED ON THE ORIGINAL INSTRUMENT AND ON AN ALTERNATE METHODOLOGY WHICH RESULTED IN THE NORMAL REFERENCE RANGE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1