COBAS® PCR MEDIA DUAL SWAB SAMPLE KIT

Additional Manufacturer Narrative

AS STATED IN THE COBAS PCR MEDIA DUAL SWAB SAMPLE KIT INSTRUCTIONS FOR USE, AVOID CONTACT OF THE COBAS PCR MEDIA WITH THE SKIN, EYES OR MUCOUS MEMBRANES. IF CONTACT DOES OCCUR, IMMEDIATELY WASH WITH LARGE AMOUNTS OF WATER. THE SAFETY DATA SHEET FOR THE MEDIA FURTHER STATES IT IS HARMFUL IF SWALLOWED. CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. KEEP RESPIRATORY TRACT CLEAR. NO HARM OR SERIOUS INJURY WAS ALLEGED, AND THE PATIENT DID NOT SEEK ANY SPECIFIC MEDICAL ATTENTION. THE CUSTOMER INDICATED THAT THEY FOLLOWED UP WITH THE PATIENT AND THE ISSUE IS NOW CLOSED; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE UDI FOR THE COBAS PCR MEDIA DUAL SWAB SAMPLE KIT IS (B)(4).

Description of Event or Problem

A (B)(6) CUSTOMER STATED THAT ONE OF THEIR PATIENTS WAS ISSUED A SELF COLLECTION SWAB AND PUT COBAS® PCR MEDIA IN HER MOUTH. THE PATIENT FELT NUMBNESS ON TONGUE AND LIPS. NO MEDICAL TREATMENT WAS PROVIDED; THE PATIENT WAS INSTRUCTED TO DRINK A LOT OF WATER. THERE IS NO INDICATION OF HARM OR SERIOUS INJURY.