KIT COBAS PCR MEDIA 100T IVD
Received Feb 1, 2021 · Event occurred Jan 8, 2021
Report 2243471-2021-00194 · MDR key 11258117
Device
Generic name
Specimen Collection Kit
Manufacturer
Roche Molecular Systems, Inc.Model number
NACatalog number
06466281190
Lot number
NA
Product problems
- Off-Label Use
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Off-Label Use
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Chemical Exposure
- Chemical Exposure
Narrative
Additional Manufacturer Narrative
THE COBAS PCR MEDIA KIT INSTRUCTIONS FOR USE INDICATES THE FOLLOWING: AVOID CONTACT OF THE COBAS PCR MEDIA WITH THE SKIN, EYES OR MUCOUS MEMBRANES. IF CONTACT DOES OCCUR, IMMEDIATELY WASH WITH LARGE AMOUNTS. HARMFUL IF SWALLOWED HAZARD WARNING. IF SWALLOWED: CALL A POISON CENTER/DOCTOR IF YOU FEEL UNWELL. RINSE MOUTH. (B)(4).
Description of Event or Problem
A (B)(6) CUSTOMER REPORTED THAT AN ELDERLY PATIENT INGESTED COBAS PCR MEDIA WHEN ATTEMPTING TO COLLECT A SALIVA SPECIMEN FOR COVID TESTING. IT WAS REPORTED THAT A PHYSICIAN CHECKED THE PATIENT AND REQUESTED THE SAFETY DATA INFORMATION FOR THE MEDIA. IT IS UNKNOWN HOW MUCH WAS ACTUALLY INGESTED, SWALLOWED OR LICKED. THE PATIENT'S CONDITION IS UNKNOWN, AND THERE WAS NO SERIOUS INJURY OR HARM REPORTED TO DATE.