VITEK® 2 GN TEST KIT
Received Mar 7, 2017
Report 1950204-2017-00081 · MDR key 6385695
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 FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN ESCHERICHIA COLI URINE SAMPLE AS SHIGELLA SONNEI IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THE ISOLATE WAS TESTED FOUR (4) TIMES WITH VITEK® 2 GN AND RECEIVED AN IDENTIFICATION OF SHIGELLA SONNEI. THE ISOLATE WAS SENT TO A STATE LABORATORY FOR SEROLOGY TESTING (MALDI-TOF) AND THE ISOLATE WAS DETERMINED TO BE ESCHERICHIA COLI. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.
Additional Manufacturer Narrative
A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN ESCHERICHIA COLI URINE SAMPLE AS SHIGELLA SONNEI IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. TESTING INCLUDED BOTH A CUSTOMER LOT AND A RANDOM LOT OF VITEK® 2 GN CARDS. API® 20 E WAS ALSO PERFORMED. ALL CARDS TESTED GAVE AN EXCELLENT ID (99%) OF S. SONNEI. API® 20 E, HOWEVER, GAVE A GOOD IDENTIFICATION (92.3%) OF E. COLI. A COMPARISON OF EXPECTED REACTION RESULTS FOR E. COLI RESULTED IN THREE (3) ATYPICAL NEGATIVE REACTIONS (DSOR, PHOS, LDC), WHICH LED TO THE MISIDENTIFICATION. IT SHOULD BE NOTED THAT, WHEN AN IDENTIFICATION OF SHIGELLA IS MADE BY VITEK® 2 GN CARDS, AN ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" IS GIVEN. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. ROOT CAUSE: ATYPICAL STRAIN.