BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 1897070 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01215
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010 AT 11:00AM, CONTROLS WERE RUN AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES; HOWEVER, AT 7:30 PM THE CONTROLS WERE RAN AND HIGH RESULTS WERE REPORTED. THE CUSTOMER REPLACED THE CREM REAGENT, PRIMED THE CUP AND REPEATED THE QC WHICH RESULTS IN LOW RANGE. A BCI FIELD SERVICE ENGINEER (FSE) FOUND A LEAK IN THE REAGENT PUMP. FSE PERFORMED THE FOLLOWING: CLEANED THE PUMP, THE REAGENT PUMP AND REPLACED HARDWARE ON THE UNIT. MODULAR CHEMISTRY TO CUP ALIGNMENT AND CUP HEIGHT ALIGNMENT. CLEANED THE CREM REACTION CUP ASSEMBLY. CALIBRATED THE UNIT. RAN CONTROLS AND PRECISION TEST. NO ADDITIONAL INFORMATION ARE AVAILABLE. THE FOLLOWING MEDWATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-01177, 2050012-2010-01216, 2050012-2010-01217, 2050012-2010-01218.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS CREATININE MODULAR (CREM) RESULTS ON MULTIPLE PATIENTS GENERATED BY THE SYNCHRON LX 20 PRO CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED ON AN ALTERNATE UNIT AND LOWER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED FOR THE SAMPLES WHERE THE DIFFERENCES IN THE RESULTS WERE OUTSIDE THE NORMAL RANGE. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX-20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR