BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2150003 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02833
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND EMPTIED THE OVERFLOW AND FOUND THE PERI-PUMP PRESSURE COVER WAS NOT SEATED CORRECTLY. FSE PRIMED INSTRUMENT 40 TIMES AND NO FLUID WAS OVERFLOWING. FSE RAN CTA CARRYOVER TESTING AND ALL PASSED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OVER FLOW BOTTLE ON THE CLOSED TUBE ALIQUOTTER (CTA) OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WAS OVERFLOWING. 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