COBAS AMPLICOR / COBAS TAQMAN HCV TEST

Additional Manufacturer Narrative

(B)(4). DEVICE EVALUATED BY MANUFACTURER - YES. RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATION. CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS; NO DEVICE FAILURE; USER ERROR CAUSED EVENT. A CUSTOMER SITE IN THE U.S. IS REPORTING THAT, WHILE DISPOSING OF SAMPLE PROCESSING UNIT (SPU) WASTE FROM A TEST RUN WITH THE (B)(6) TEST , LIQUID WAS SPLASHED FROM THE BIOHAZARD TRASH CONTAINER INTO A TECHNICIAN'S MOUTH AND ONTO HIS FACE. THE CUSTOMER HAS NO HISTORY OF (B)(6) INFECTION AND WAS NOT ON ANY MEDICATIONS AT THE TIME. ALTHOUGH THE CUSTOMER COULD NOT REMEMBER IF HE SWALLOWED ANY OF THE WASTE THAT WAS SPLASHED INTO HIS MOUTH, HE STATED THAT HE HAD NO SIGNS OR SYMPTOMS OF INGESTION. THE CUSTOMER STATED THAT SPUS FROM AN (B)(6) TEST RUN WERE ALSO PRESENT IN THE BIOHAZARD CONTAINER AT THE TIME THE SPLASH OCCURRED. AS OF (B)(6) 2011, THE CUSTOMER STATED THAT HIS CONDITION HAD NOT CHANGED, HE HAD NOT RECEIVED ANY TREATMENT, AND HE WAS NOT SHOWING ANY SIGNS OR SYMPTOMS OF INFECTION. BLOOD WAS DRAWN FROM THE CUSTOMER AND RESULTS FROM ALL TESTING WERE NEGATIVE. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED DURING THE INVESTIGATION. THE EVENT WAS CAUSED BY USER ERROR. THE COBAS AMPLIPREP OPERATOR MANUAL (08-2005, REVISION 2.0) PROVIDES GUIDELINES FOR DISPOSAL OF USED SPUS IN SECTION 3 - OPERATION - REMOVING USED CONSUMABLES. IN ADDITION TO PROVIDING A WARNING TO TAKE UNIVERSAL SAFETY PRECAUTIONS WHEN HANDLING WASTE, IT ALSO PROVIDES SPECIFIC INSTRUCTIONS FOR DISPOSAL OF SPUS WHICH INCLUDES: WEAR A LABORATORY COAT, DISPOSABLE GLOVES AND SAFETY GLASSES WITH SIDE SHIELDS (OR GOGGLES) WHEN DISPOSING OF USED SPUS HOLD THE RACK OF SPUS WITHIN SIX INCHES OF THE TOP OF THE BIOHAZARD CONTAINER. THE TOPS OF THE SPUS SHOULD BE FACING UP AND TILTED TO AN ANGLE ( 20- 45 DEGREES) FROM VERTICAL SO THAT THE OPENING FACES AWAY FROM THE OPERATOR. SLOWLY REMOVE ONE SPU AT A TIME, AND GENTLY DROP IT INTO THE BIOHAZARD CONTAINER. HOLD THE SPU AT AN ANGLE ( 20- 45 DEGREES) FROM VERTICAL SO THAT THE OPENING FACES AWAY FROM THE OPERATOR. CHECK THE LEVEL OF WASTE IN THE BIOHAZARD CONTAINER AND EMPTY OR REPLACE THE CONTAINER WHEN IT IS HALF-FULL. (B)(4).

Description of Event or Problem

A CUSTOMER SITE IN THE US IS REPORTING THAT, WHILE DISPOSING OF SAMPLE PROCESSING UNIT (SPU) WASTE FROM A TEST RUN WITH THE CAP/CTM HCV TEST , LIQUID WAS SPLASHED FROM THE BIOHAZARD TRASH CONTAINER INTO A TECHNICIAN'S MOUTH AND ONTO HIS FACE. NO TREATMENT WAS OBTAINED AND NO SYMPTOMS WERE PRESENT. THE TECHNICIAN DID RINSE HIS MOUTH AND REMOVED HIS CLOTHING. THE TECHNICIAN HAD BLOOD DRAWN FOR BASELINE TESTING. THE RESULTS OF THIS TESTING ARE NOT YET AVAILABLE.

Additional Manufacturer Narrative

A CONCLUSION CANNOT BE DRAWN AT THIS TIME AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE INVESTIGATION CONCLUSIONS WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).