BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2242252 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05209
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYRINGES AND REPLACED THE T-VALVE ASSEMBLY FOR THE MODULAR CHEMISTRY SAMPLE, CARTRIDGE CHEMISTRY SAMPLE AND CARTRIDGE CHEMISTRY REAGENT SYRINGE DRIVES. ADDITIONALLY THE LEVEL SENSE BEAD WAS REPLACED. UPON MAKING THE NECESSARY VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. THESE REPAIRS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUSLY LOW OR SUPPRESSED CREATININE (CR-S), BLOOD UREA NITROGEN (BUN), TOTAL PROTEIN (TP), TOTAL BILIRUBIN (TBIL), ALKALINE PHOSPHOTASE (ALP), ASPARTATE AMINOTRANSFERASE (AST) AND/OR ALANINE TRANSAMINASE (ALT) RESULTS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR TWO PATIENTS. THE ERRONEOUS INITIAL RESULTS AND SUPPRESSED RESULTS WERE CAUSED BY THE SAME INSTRUMENT MALFUNCTION(S). THE ERRONEOUS OR SUPPRESSED INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE NO DEATHS, SERIOUS INJURIES OR CHANGES TO PATIENT TREATMENT WERE ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT ASSAY QUALITY CONTROL RESULTS GENERATED PRIOR TO THE EVENT WERE OUTSIDE OF CUSTOMER ESTABLISHED SPECIFICATIONS FOR TBIL. THE INSTRUMENT HAD EXPERIENCED LEVEL SENSE AND SAMPLE DETECTION ERRORS DURING THE TIMEFRAME OF THIS EVENT. NO SAMPLE HANDLING/COLLECTION INFORMATION OR ADDITIONAL SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1