VITEK® 2 GN TEST KIT
Received Mar 8, 2017
Report 1950204-2017-00084 · MDR key 6388983
Device
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GN TEST KIT ((B)(4)) RELATED TO MISIDENTIFICATION OF PSEUDOMONAS AERUGINOSA AND BREVUNDIMONAS DIMINUTA INSTEAD OF RHODOCOCCUS EQUI. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFIED RHODOCOCCUS EQUI AS PSEUDOMONAS AERUGINOSA AND BREVUNDIMONAS DIMINUTA FOR AN EEQ SURVEY SAMPLE IN ASSOCIATION WITH VITEK® 2 GN TEST KIT (UDI (B)(4)). AN INVESTIGATION WAS PERFORMED. PREVIOUS REFERENCE TESTING HAS IDENTIFIED THIS ISOLATE AS RHODOCOCCUS EQUI. RHODOCOCCUS EQUI IS OUT OF THE GN CARD KNOWLEDGE BASE. THERE IS A LIMITATION ON VITEK® 2 FOR SPECIES NOT CLAIMED IN THE KNOWLEDGE BASE. NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.