4C PLUS COULTER CELL CONTROL
Received Jun 15, 2011 · Event occurred Oct 15, 2008
Report 1061932-2011-00570 · MDR key 2175323
Device
Product problems
- Fluid/Blood Leak
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTED ONE OF THREE LEVELS OF THE 4C PLUS COULTER CELL CONTROL AS LEAKING. THE 4C PLUS COULTER CELL CONTROL VIAL THAT WAS REPORTED AS LEAKING WAS NOT EVALUATED. A FIELD SERVICE ENGINEER DID EVALUATE THE COULTER AC-T DIFF 2 ANALYZER AND ALIGNED THE PIERCING MECHANISM. ROOT CAUSE COULD HAVE BEEN ASSOCIATED WITH A MISALIGNMENT OF THE PIERCING MECHANISM ON THE COULTER AC-T DIFF 2 ANALYZER. HOWEVER, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL BIOHAZARD EVENT OF A LEAK FROM THE STOPPER OF A NORMAL CONTROL VIAL WHEN USING THE 4C PLUS COULTER CELL CONTROL AND A COULTER AC-T DIFF 2 ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT WHEN THE EVENT OCCURRED ON (B)(6) 2008. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN LESION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.