BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 2983609 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00272
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE (FSE) FOUND THAT THE PROBE WAS LEAKING. UPON FURTHER INSPECTION, THE FSE DISCOVER THE PINCH VALVE LV8 WHICH CONTROLS THE PATH FROM THE PROBE WASH DRAIN TO THE VACUUM ISOLATOR CHAMBER WAS NOT CLOSING PROPERLY. THE FSE REPLACED THE PINCH VALVE LV8 AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS THAT THE PINCH VALVE LV8 WAS NOT CLOSING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, (BEC), A LEAK AT THE PROBE OF THE COULTER ACT DIFF 2 ANALYZER. THE VOLUME OF THE LEAK WAS A FEW DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE NOT IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF THE EVENT. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85717 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1