BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3545701 · Received December 31, 2013

    Report

    Report Number
    1061932-2013-02991
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND ADJUSTED THE PROBE WASH COLLAR ALIGNMENT AND REPEATED THE SHUTDOWN CYCLE, NO FURTHER DRIPPING WAS OBSERVED. WHILE ONSITE, THE CUSTOMER ALSO REPORTED THAT INSTRUMENT ATTEMPTS TO SAMPLE CASSETTE POSITION #5 INTERMITTENTLY WHEN THERE IS NOT A TUBE IN THAT POSITION. THE FSE ADJUSTED THE PHYSICAL POSITION OF SCANNER, PERFORMED BARCODE ALIGNMENT, AND BARCODE READ RATE, AND RESOLVED THE PROBLEM. IDENTIFIED FAILURE MODES: THE FAILURE MODE COULD BE ATTRIBUTED TO A MISALIGNED PROBE WASH COLLAR AND A MISALIGNED BARCODE. NO ERRONEOUS RESULTS WERE GENERATED FOR THIS EVENT. A MISALIGNED PROBE WASH COLLAR IS LIKELY TO GENERATE ERRONEOUS RESULTS FOR ALL PARAMETERS DUE TO CARRYOVER OR SAMPLE CONTAMINATION. A MISALIGNED BARCODE CAN CAUSE INCORRECT COMPLETE BLOOD COUNT (CBC)/DIFFERENTIAL AND RETICULOCYTE PARAMETERS RESULTS DUE TO SAMPLE ID MISIDENTIFICATION, FALSE RESULT CAN BE REPORTED TO PHYSICIAN WHEN PATIENT IS ACTUALLY WITHIN NORMAL PARAMETERS. EVALUATION OF PRODUCT LABELING: PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS DESCRIBED AS 2 ML OF CLENZ THAT LEAKED UNDERNEATH THE BSV (BLOOD SAMPLING VALVE) TRAY OF THE INSTRUMENT. THE LEAK WAS CONTAINED. THE OPERATOR WAS WEARING GLOVES, EYE PROTECTION, AND LABCOAT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681842 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1