BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 1844409 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00807
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE REAGENT PREPARATION FOR THE 2X400 TEST KIT, THE CUSTOMER DID NOT TRANSFER THE A-REAGENT FROM A SEPARATE BOTTLE INTO COMPARTMENT A OF THE REAGENT CARTRIDGE. BCI CUSTOMER TECHNICAL SUPPORT ORDERED A REPLACEMENT REAGENT FOR THE CUSTOMER. USER ERROR IS A ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW CK RESULTS GENERATED BY SYNCHRON CX DELTA CLINICAL SYSTEM. THE RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER REPEATED THE TESTS ON A NEWLY PREPARED REAGENT AND OBTAINED CORRECT RESULTS. THERE WAS NO EFFECT TO THE PATIENTS OR TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JLB BECKMAN COULTER, INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1