BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL SYSTEMS

    MDR report key: 1951773 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00044
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC WAS NOT RUN POST THE EVENT (PRIOR TO RECALIBRATION). A BCI FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT WHICH PASSED PERFORMANCE SPECIFICATION. ON (B)(4) 2010 MAINTENANCE WAS PERFORMED ON THE INSTRUMENT. FSE NOTED CHANGE IN CALIBRATION RECOVERY IMMEDIATELY AFTER THE MAINTENANCE AND ATTRIBUTED THE CHANGE TO THE CALIBRATION. FSE MONITORED THE ACCOUNT AND DID NOT NOTE RECOVERY SHIFT POST NEWLY PERFORMED MAINTENANCE. ON (B)(4) 2010 MAINTENANCE WAS PERFORMED ON ANOTHER UNIT, WHICH ALSO EXHIBITED SIMILAR ISSUE. MED-WATCH # 2050012-2011-00043 IS ASSOCIATED WITH THE OTHER UNIT. ROOT CAUSE FOR THIS EVENT IS MAINTENANCE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS GENERATED BY THE SYNCHRON LX 20 CLINICAL SYSTEM SEVERAL HOURS AFTER PERFORMING MAINTENANCE. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN A TOTAL OF 159 SAMPLES WERE RERUN ON EITHER THE SAME UNIT OR AN ALTERNATE UNIT AND HIGHER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. DATA ARE NOT AVAILABLE AND THE CUSTOMER STATED THAT THE ORIGINAL NA RESULTS RECOVERY DROPPED 6-10 MMOL/L. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1