BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2182606 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03821
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    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

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MODULAR CHEMISTRY SAMPLE SYRINGE, SAMPLE PLUNGER, REAGENT SYRINGE AND PHOTOMETER LAMP. THE FSE ADJUSTED THE FOAM SENSOR AND CLEANED THE HYDROPNEUMATICS SYSTEM. THE FSE ALSO PROACTIVELY COMPLETED AN INSTRUMENT PREVENTIVE MAINTENANCE PROCEDURE. ALTHOUGH REPAIRS WERE MADE TO THE INSTRUMENT PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS HIGH MICROALBUMIN (MA) RESULTS AND CAFFEINE (CAFF) RESULTS WERE GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR TWO PATIENTS. UPON REPEAT, DIFFERENT MA AND CAFF RESULTS WERE GENERATED THAT WERE MORE BELIEVABLE AND REGARDED AS CORRECT. THE INITIAL MA RESULT WAS RELEASED FROM THE LABORATORY HOWEVER THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CAFF INITIAL RESULT WAS NOT RELEASED FROM THE LABORATORY. NO OTHER CHEMISTRY RESULTS ON ANY OTHER SAMPLES WERE QUESTIONED OR REPEATED. PRIOR TO THE EVENTS, CAFF AND MA QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THERE WERE NO INSTRUMENT ERROR MESSAGES OR SAMPLE RESULT FLAGS GENERATED. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER IDENTIFIED ISSUES WITH THE HYDROPNEUMATIC SYSTEM SUCH AS FILLED ACCUMULATORS AND FOAM/GEL TYPE SUBSTANCES IN THE VACUUM ACCUMULATOR AND WASTE SUMP ASSEMBLY.

    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