VITEK® 2 GN TEST KIT
Received Mar 29, 2017
Report 1950204-2017-00100 · MDR key 6441987
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 ORGANISM WAS SUBBED AND TESTING INCLUDED BOTH THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS. API 20 E WAS ALSO PERFORMED. ON ALL CARDS TESTED, A SLASHLINE ID OF SHIGELLA GROUP WAS OBTAINED. API 20 E, HOWEVER, IDENTIFIED THE ORGANISM AS E. COLI (99.8%). THEREFORE, THE FINAL IDENTIFICATION IS E. COLI. IT SHOULD BE NOTED THAT, ON LABORATORY REPORTS GIVING EITHER SHIGELLA OR SALMONELLA, AN ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" APPEARS. A COMPARISON OF CARD REACTION RESULTS FOR SALMONELLA AGAINST EXPECTED REACTION RESULTS FOR E. COLI REVEALED FIVE (5) ATYPICAL NEGATIVE REACTIONS (BGAL, SUCT, PHOS, GLYA, BGUR) WHICH LED TO THE MISIDENTIFICATION. A COMPARISON OF CARD REACTION RESULTS FOR SHIGELLA GROUP AGAINST EXPECTED REACTION RESULTS FOR E. COLI REVEALED SIX (6) ATYPICAL NEGATIVE REACTIONS (BGAL, DMAL, SUCT, PHOS, GLYA, BGUR) WHICH LED TO THE MISIDENTIFICATION. THIS IS AN ATYPICAL STRAIN.
Description of Event or Problem
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GN TEST KIT (REFERENCE 21341) RELATED TO MISIDENTIFICATION OF AN ORGANISM. THE CUSTOMER REPORTED RESULTS FROM A URINE ISOLATE. THE ORGANISM GREW FROM A PURE URINE CULTURE AT 35 DEGREES IN NON-CO2 INCUBATOR. IT WAS A NON-LACTOSE FERMENTING ORGANISM AND THE VITEK® ID CARD IDENTIFIED THE ORGANISM AS SALMONELLA BOTH TIMES. THE SEROLOGY FOR SALMONELLA WAS NEGATIVE AND THE CUSTOMER SENT THE ORGANISM TO THEIR REFERENCE LABORATORY WHICH IDENTIFIED THE ORGANISM AS E. COLI. THE "MALDIT" OF IDENTIFICATION WAS ALSO E. COLI AND SIMPLE TESTS SHOWED THE FOLLOWING REACTIONS: INDOLE +/-, LACTOSE NEGATIVE, TSI= A/A NO H2S. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THERE WAS A DELAY IN THE FINAL REPORT UNTIL CONFIRMATION IDENTIFICATION WAS RECEIVED FROM BCCDC. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.