VITEK® 2 GN TEST KIT
Received May 22, 2017
Report 1950204-2017-00161 · MDR key 6583177
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
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE REFERENCE METHOD (SEQUENCING FULL 16S) USED TO DETERMINE THE INTENDED RESULT, GIVES AN EXCELLENT IDENTIFICATION TO THE SPECIES ESCHERICHIA COLI (100%). THE VITEK® MS V3 (KNOWLEDGE BASE V3.0) CONFIRMED THIS RESULT. THE INCRIMINATED PRODUCT, VITEK®2 V7.01 GN CARDS FROM CBA AND XLD SUBCULTURES (CUSTOMER LOT 2410022403, CL & RANDOM LOT 241398620, RL), GIVES: VERY GOOD IDENTIFICATION TO THE SPECIES E. COLI (95%) ON THE CL WITH CBA SUBCULTURES. EXCELLENT IDENTIFICATION TO SALMONELLA ENTERICA SSP ARIZONAE (96%) ON THE RL FROM CBA SUBCULTURES AND ON BOTH LOTS TESTED FROM XLD SUBCULTURES. THE CUSTOMER MISIDENTIFICATION IS DUPLICATED 3/4 ON GN CARD. ACCORDING TO THE COMPARISON OF BIOCHEMICAL PROFILES OBTAINED ON VITEK®2, THE MISIDENTIFICATION TO S. ENTERICA SSP ARIZONAE IS DUE TO ATYPICAL RESULTS FOR 2 DISCRIMINATING TESTS BETWEEN THE SPECIES E. COLI AND S. ENTERICA SSP ARIZONAE : H2S AND ELLM. ROOT CAUSE WAS IDENTIFIED AS ATYPICAL PROFILE ON VITEK®2. IT SHOULD BE NOTED THAT, ON LAB REPORTS GIVING SALMONELLA, AN ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" APPEARS.
Description of Event or Problem
A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX A TWICE MISIDENTIFIED SALMONELLA ENTERICA STRAIN AS SALMONELLA ENTERICA SPP. ARIZONAE FOR AN ANIMAL FECAL SAMPLE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT (UDI (B)(4)). THE CUSTOMER REPORTED TESTING THE STRAIN TWICE ON VITEK® 2 GN AND RAN PURITY PLATES PRIOR TO THE SECOND TEST BUT THE RESULTS WERE THE SAME. THE CUSTOMER STATED THEY DID NOT DO CONFIRMATION TESTING, AS ALL THE POSITIVE STRAINS ARE SENT TO THE (B)(4) AS IS REQUIRED BY LAW. THE (B)(4) CONFIRMED THE STRAIN WAS NOT SALMONELLA. THE CUSTOMER STATED THE VITEK® 2 IS UP TO DATE WITH MAINTENANCE AND THERE IS NO ISSUE WITH QUALITY CONTROL TESTS. THERE IS NO INDICATION OR REPORT TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.