BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2372743 · Received December 12, 2011

    Report

    Report Number
    2122870-2011-05994
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    July 11, 2007
    Report Date
    July 11, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED A TROUBLESHOOTING ON (B)(4) 2007 AND SYSTEM CHECK FAILED. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2007. THE FSE PERFORMED PREVENTIVE MAINTENANCE (PM), REPLACED THE MIXER ASSEMBLY AND THE INCUBATOR BELT. THE FSE REPLACED ALL PARTS IN THE PREVENTIVE MAINTENANCE (PM) KIT AND COMPLETED SYSTEM CHECK, LUMWASH SON INC DIAGNOSTIC TEST, AND PRECISION TEST SUCCESSFULLY. THE UNIT CONFORMED TO THE MFR'S SPECIFICATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM 01/01/2008 THROUGH 10/23/2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED TROPONIN I (ACCUTNI) RESULT, FOR ONE PT, INVOLVED UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SUBSEQUENT TESTING ON AN ALTERNATE UNICEL DXC 600I. SYSTEM PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE INTERVAL. THE ELEVATED RESULT DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) TRAVELED TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI| UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM