BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2122592 · Received June 14, 2011

    Report

    Report Number
    2050012-2011-02334
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED FOR THIS INCIDENT. THE FIELD SERVICE ENGINEER REMOVED THE INSTRUMENT'S TOP COVERS AND REAR FAN COVERS. HE REMOVED THE POWER SUPPLY AND FOUND NO EVIDENCE OF BURNING. THE CUSTOMER STATED THAT SHE WAS UNCERTAIN THAT THE SMELL WAS GENERATED BY THE DEVICE. A DEFINITE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2010 A FAINT BURNING ODOR WAS NOTED AS COMING FROM THE UNICEL DXC 600 SYNCHRON SYSTEM AFTER A BECKMAN COULTER INC. (BCI) FIELD SERVICE VISIT WHERE THE SMART MODULE WAS REPLACED ON THE UNIT. ACCORDING TO THE CUSTOMER THE SMELL DISSIPATED QUICKLY. INSTRUMENT QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS. THERE WERE NO ERROR MESSAGES GENERATED AS A RESULT OF THIS INCIDENT AND THE SYSTEM REMAINED OPERATIONAL. THERE WAS NO VISIBLE SMOKE, SPARKS, FLAME OR ARCING OBSERVED FROM THE DEVICE. THE LABORATORY WAS NOT EVACUATED AND THE FIRE DEPARTMENT WAS NOT CALLED. THE CUSTOMER WAS NOT INJURED AND DID NOT SEEK MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. THERE WAS NOT DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. NO PROBLEMS OF THIS NATURE HAVE BEEN REPORTED BY THE CUSTOMER SINCE THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1