BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3171771 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01110
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INDICATED THAT THE CUSTOMER ATTEMPTED BLEACHING THE SYSTEM AND WAS ABLE TO CLEAR AN APPARENT CLOG IN THE WASTE SYSTEM PRIOR TO THE SERVICE VISIT, WHICH RETURNED THE INSTRUMENT TO NORMAL OPERATION. AS PREVENTIVE MAINTENANCE, THE WASTE FILTER, TUBING AND HYDROPHILIC FILTERS WERE REPLACED BY THE FSE. THE CAUSE OF THE LEAK CAN BE ATTRIBUTED TO A CLOG IN THE SYSTEM WHICH CONTRIBUTED TO POOR BATH DRAIN AND THE REPORTED BATH OVERFLOW. HOWEVER, THE INSTRUMENT PERFORMED AS EXPECTED, GENERATING A VACUUM ERROR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A SAMPLE ON THE COULTER AC *T DIFF 2 ANALYZER THE BATHS STARTED OVERFLOWING. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT ALSO RECOVERED A VACUUM ERROR. THE CUSTOMER WAS ADVISED TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE), TO POWER THE INSTRUMENT DOWN AND THEN BACK UP BUT WAS UNABLE TO GET THE INSTRUMENT BACK ON. THE ACT DIFF 2 IS LOCATED WITHIN A FLOW CYTOMETRY LAB, AND IT IS USED SOLELY TO SET CONCENTRATION LEVELS FOR THEIR FLOW COUNTS. THIS UNIT DOES NOT RUN 4C/4C ES CONTROLS. THE CUSTOMER USES A PATIENT OF KNOWN VALUES AND COMPARES RESULTS WITH THE VALUES THE MAIN LAB RECOVERS. THE DIFFERENCE BETWEEN THE TWO, WERE WITHIN ACCEPTABLE ESTABLISHED LAB LIMITS. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS INCIDENT. NO PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITHI THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273229 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1