BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS

    MDR report key: 2211045 · Received August 14, 2011

    Report

    Report Number
    2050012-2011-04272
    Event Type
    Malfunction
    Date Received
    August 14, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM. NO ADDITIONAL SAMPLE INFORMATION WAS PROVIDED. QC WAS PROVIDED FROM (B)(6) 2011 ONLY AND LOW LEVEL NA QC WAS OUT OF RANGE LOW. QC WAS REPEATED 7 HOURS LATER AND IT WAS WITHIN LABORATORY ESTABLISHED RANGE. PER CUSTOMER, CO2 ALK BUFFER LINE 30 AND DAMPER LOOKED CLOUD. A BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE CHLORIDE TIP AND CARBON DIOXIDE ELECTRODES. FSE VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULT ON 1 PATIENT SAMPLE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE LABORATORY WAS ALERTED OF A LOW ANION GAP AND THE SAMPLE WAS REPEATED ON AN ALTERNATE DXC AND HIGHER RESULTS WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JGS BECKMAN COULTER INC. DXC 600PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1