BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2252059 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05572
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS AN EMPTY AND FULL ALB CARTRIDGE ON THE SYSTEM. THE CUSTOMER REMOVED THE EMPTY CARTRIDGE, AND PERFORMED A QUALITY CONTROL (QC) RUN. RESULTS WERE WITHIN ESTABLISHED RANGES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH ALBUMIN (ALB) RESULTS ON A UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR TWO (2) PATIENTS. THE CUSTOMER PROVIDED RESULTS FOR ONE PATIENT. REPEAT TESTING OF THE SAMPLES ON AN ALTERNATE INSTRUMENT GENERATED LOWER RESULTS. THE INSTRUMENT GENERATED A CC (CHEMISTRY CARTRIDGE) REAGENT CARTRIDGE NO FLUID DETECTED ERROR FOLLOWED BY A CC CUVETTE NO FLUID DETECTED ERROR DURING THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, THUS DID NOT AFFECT PATIENT DIAGNOSIS OR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR