BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC T 5DIFF CONTROL PLUS

    MDR report key: 2276810 · Received September 23, 2011

    Report

    Report Number
    1061932-2011-01514
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    003534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMER 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 LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. THE COULTER AC T 5DIFF CONTROL PLUS IS A HEMATOLOGY QUALITY CONTROL MATERIAL USED TO MONITOR THE PERFORMANCE OF THE COULTER AC T 5DIFF HEMATOLOGY ANALYZERS. PICTURES OF THE VIAL WERE EVALUATED. THE RUBBER PART IN THE CAP OF THE HIGH CONTROL VIAL LEAKED WHEN PIERCED. SERVICE WAS NOT DISPATCH FOR THIS EVENT. BASED ON AVAILABLE INFO, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COULTER AC T 5DIFF CONTROL PLUS (HIGH LEVEL CONTROL VIAL) LEAKED WHILE LYING FLAT ON THE COUNTER TOP. THE CONTROL HAD BEEN PIERCED; HOW MANY TIMES IS UNK. THE POTENTIAL FOR BIOHAZARD EXPOSURE WITH THE REPORTED INCIDENT WAS PRESENT. IN ADDITION, THE CONTROL WAS RUN AND THE RECOVERY RESULTS WERE ELEVATED. THIS WAS NOTED DUE TO INCORRECT CONCENTRATION OF CELL SUSPENSION DUE TO MISSING DILUTING FLUID (LEAK). THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. IT IS UNK IF THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED, HOWEVER, IT IS READILY AVAILABLE. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT AS A RESULT OF THIS EVENT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THE PRODUCT WAS REPLACED AND ALL ISSUES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC T 5DIFF CONTROL PLUS JPK BECKMAN COULTER, INC. NA 0309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER