BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL ANALYZER

    MDR report key: 2242244 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05038
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K071277
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE OBSERVED THAT THE EIC VALVE WAS NOT MAKING A GOOD SEAL WITH THE EIC BLOCK, CAUSING ELECTROLYTE REFERENCE REAGENT TO DRY ON THE SIDE OF THE VALVE. THE FSE REPLACED THE EIC BLOCK BOTTOM AND PERFORMED AN ISE HEALTH CHECK; NO PROBLEMS WERE NOTED BY FSE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING IT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A BUILDUP OF CRUSTY BLUE MATERIAL UNDER THE ELECTROLYTE INJECTION CUP (EIC) VALVES IN THE SYNCHRON LX20 PRO CLINICAL ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 CLINICAL ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1