BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1813499 · Received August 24, 2010

    Report

    Report Number
    2050012-2010-00618
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THEY DID NOT NEED REAGENT REPLACEMENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND PERFORMED LAMP VOLTAGE ADJUSTMENT AND CALIBRATION AFTER FINDING IT LOW AND OUT OF SPECIFICATION. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A BUN REAGENT CARTRIDGE LEAKED. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR