BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1771102 · Received July 27, 2010

    Report

    Report Number
    2050012-2010-00487
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TIGHTENED THE LOOSE FITTING ON THE REAGENT PROBE THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CUSTOMER REQUESTED SERVICE TO CONFIRM THE LOOSE FITTING ISSUE AND THAT THE UNIT IS OPERATING ACCORDINGLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW AMYLASE RESULT GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND HIGHER RESULT WAS OBTAINED. THE SAMPLE WAS RERUN ON A DIFFERENT UNIT TO HIGHER RESULT WAS CONFIRMED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1