BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)

    MDR report key: 1890408 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01172
    Date Received
    November 3, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED AND REPAIRED A LEAKING REAGENT PUMP SYRINGE. FSE PERFORMED CALIBRATION AND QC; BOTH PASSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CREATININE MODULE OVERFLOW. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1