KIT ELECSYS CLEAN-CELL M 2X2 L

Description of Event or Problem

THE CUSTOMER EXPERIENCED THE CLEAN CELL SOLUTION SPLASHING INTO HER EYE WHILE PUTTING THE SOLUTION ONTO THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THE CUSTOMER STATED THE BOTTLE WAS REALLY FULL AND HEAVY AND WHEN SHE PICKED IT UP TO PUT IT IN POSITION ON THE ANALYZER, THE BOTTLE SLIPPED CAUSING HER TO SQUEEZE THE BOTTLE AND SPLASH THE CLEAN CELL INTO HER EYE. SHE DID NOT NOTE ANY DEFECT WITH THE BOTTLE. THE CUSTOMER VISITED THE ER WHERE HER EYE WAS FLUSHED WITH WATER FOR 15 MINUTES. SHE ALSO RECEIVED A TETANUS SHOT AND ANTIBIOTICS FOR THE INJURY. THE CUSTOMER'S EYE WAS RED AND INFLAMED. HER DIAGNOSIS WAS "CHEMICAL CONJUNCTIVITIS/CHEMICAL BURN TO LEFT EYE." THE CUSTOMER WAS DISMISSED FROM WORK FOR FIVE DAYS BY THE PHYSICIAN AND WAS TO FOLLOW UP WITH AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST PUT ARTIFICIAL TEARS IN HER EYE AND STATED THERE WAS NO PERMANENT DAMAGE TO HER EYE. SHE RETURNED TO WORK (B)(6) 2013 AND STATED SHE WAS NOT HAVING ANY PROBLEMS DUE TO THE EVENT.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A CUSTOMER HANDLING ISSUE. PRODUCT LABELING PROVIDES INSTRUCTIONS TO THE CUSTOMER TO WEAR PERSONAL PROTECTIVE EQUIPMENT WHEN HANDLING THE PRODUCT.