BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2192388 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02674
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE COLLECTED IN GREINER PLASMA TUBES WITH A GEL SEPARATOR, CENTRIFUGED FOR 5 MINUTES AT 4000G. THE CUSTOMER NOTED THAT THE GREINER TUBES HAVE A NEW GEL FORMULATION AND THERE WERE VISIBLE CELLS WITHIN THE GEL. THE CUSTOMER STATED THAT THEY WILL SPEAK TO GREINER REGARDING THIS ISSUE. PER THE CUSTOMER SUPPLIED QC CHARTS, BOTH LEVELS OF ACCUTNI QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. PER THE CUSTOMER, A ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THE EVENT. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE DID NOT NOTE ANY HARDWARE ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE EVENT, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO (2) PATIENTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110411) AND ACCESS ACCUTNI CALIBRATOR (LOT 023153). THE RESULTS WERE NOT REPORTED OUT OF THE LAB. REPEAT ANALYSIS OF THE PATIENTS' SAMPLES ON THE SAME INSTRUMENT YIELDED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. RESULTS ARE SHOWN. 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® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1