BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2213565 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04533
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ISSUE WAS INTERMITTENT. ON (B)(4) 2011, SERVICE WAS PERFORMED ON THIS INSTRUMENT. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE EIC WAS NOT OVERFLOWING WHEN HE ARRIVED AT THE LABORATORY. THE FSE REPLACED EIC VALVES. THREE (3) SUCCESSIVE CALIBRATIONS WERE PERFORMED AND ALL PASSED. THE FSE VERIFIED PREVIOUSLY PERFORMED SERVICE REMEDIATION ON VALVE FITTING. QC WAS TESTED AND PASSED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. AS OF (B)(4) 2011, THE CUSTOMER HAD NOT CONTACTED BEC FOR FURTHER ASSISTANCE ON THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED THAT THE EIC (ELECTROLYTE INJECTION CUP) ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS OVERFLOWING AGAIN AND THERE IS A PUDDLE ON THE FLOOR. THIS REPORT WAS AFTER SERVICE WAS PERFORMED ON (B)(4) 2011. THE EARLIER EVENT IS REPORTED IN A SEPARATE REPORT #2050012-2011-04532. THE CUSTOMER PICKED A BLIND PATIENT SAMPLE AND VERIFIED THAT THE RESULT WAS NOT AFFECTED. THE CUSTOMER USED PPE TO CLEAN THE SPILLAGE. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1