BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2317942 · Received November 1, 2011

    Report

    Report Number
    2050012-2011-05072
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CHANGE FROM: THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT ASFDAFD ASF ASDF GIVING "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" ERRORS AND REAGENT PROBE B LEAK. TO: THE CUSTOMER CONTACTED BECKMAN COULTER INC(BEC) TO REPORT UNICEL DXC 800PRO SYNCHRON CHEMISTRY ANALYZER GAVE "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" ERRORS AND REAGENT PROBE B LEAK.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC(BEC) TO REPORT UNICEL DXC 800PRO SYNCHRON CHEMISTRY ANALYZER GAVE "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" ERRORS AND REAGENT PROBE B LEAK.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC(BEC) TO REPORT ASFDAFD ASF ASDF GIVING "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" ERRORS AND REAGENT PROBE B LEAK. THE CUSTOMER WAS WEARING PPE WHEN SHE DISCOVERED THE LEAK. NO INJURY OR EXPOSURE TO THE FLUID WAS REPORTED AND PATIENT DIAGNOSIS OR TREATMENT WAS NOT IMPACTED BY THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE A/B VALVE WHICH RESOLVED THE LEAKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1