BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2091503 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01579
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. PER CUSTOMER, THEY CLEANED UP CRYSTALS THE PREVIOUS WEEK BUT THEY WERE BACK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REMOVED BOTH SYRINGE DRIVES AND REPLACED WITH NEW STYLE TECAN SYRINGE AND DRIVE. FSE PRIMED CTA 20 TIMES AND PERFORMED CARRYOVER AND ACCURACY PERFORMANCE VERIFICATION. ACCURACY WAS DONE BY VISUAL INSPECTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING CRYSTALS FORMING ON THE CLOSED TUBE ALIQUOTTER (CTA) SAMPLE SYRINGE SUGGESTED A LEAK. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1