BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2565097 · Received May 8, 2012

    Report

    Report Number
    2050012-2012-01096
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE CARTRIDGE CHEMISTRY (CC) REAGENT SYRINGE HAD A SIGNIFICANT AMOUNT OF AIR IN IT. THE FSE REPLACED THE PLUNGER AND PRIMED THE SYRINGE. THERE WAS NO LONGER AIR IN THE SYRINGE. THE FSE REPLACED THE CC SAMPLE PROBE, AS IT MAY HAVE HAD A CLOT IN IT. BLOOD UREA NITROGEN (BUN) WAS ABLE TO BE CALIBRATED AND QUALITY CONTROL (QC) WAS WITHIN RANGE. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING SEVERAL OUT OF ANALYTICAL RANGE AND SUPPRESSED OIR HI (OUT OF INSTRUMENT RANGE HIGH) AND OIR LO (OUT OF INSTRUMENT RANGE LOW) RESULTS FOR MULTIPLE PATIENTS, FOR CARTRIDGE CHEMISTRY (CC) INVOLVING UNICEL DXC 600 SYNCHRON SYSTEM. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING. THE CUSTOMER INSPECTED THE CARTRIDGE CHEMISTRY (CC) SAMPLE AND CC REAGENT SYRINGES AND INDICATED THE CC REAGENT SYRINGE WAS EASILY LOOSENED AND CONTAINED A LARGE AIR BUBBLE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS INCIDENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1