BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1838282 · Received September 17, 2010

    Report

    Report Number
    2050012-2010-00000
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) TEMPORARILY REPAIRED CANISTER LIDS AND ORDERED THE BLUE COLORED HYDRO CANISTER LIDS FOR REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE GREY COLORED HYDRO CANISTER LID ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CRACKED. NO PERSONNEL WERE EXPOSED TO CHEMICAL OR BIO-HAZARDOUS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1