BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2190004 · Received August 3, 2011

    Report

    Report Number
    2050012-2011-03926
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. FSE REPLACED THE TRICONTINENT REAGENT SYRINGE TO CORRECT THE ISSUE. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE NECESSARY REPAIRS WERE COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUSLY LOW BLOOD UREA NITROGEN (BUN) RESULT WAS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. UPON MULTIPLE REPEAT OF THE SAME SAMPLE ON ANOTHER INSTRUMENT, THE BUN RESULTS WERE HIGHER AND CONSIDERED VALID. THE INITIAL RESULTS WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. INSTRUMENT BUN QUALITY CONTROL RESULTS PRIOR TO THE EVENT HAD RESULTED IN SOME LOW OUTLIER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1