VITEK® 2 GN TEST KIT
Received Dec 13, 2016
Report 1950204-2016-00202 · MDR key 6170379
Device
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE 4 ORGANISMS WERE SUBBED, AND TESTING INCLUDED THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS. API 20 E WAS ALSO PERFORMED. ISOLATE 911255 (K. OXYTOCA): BOTH CARDS GAVE AN EXCELLENT ID (98%) OF K. PNEUMONIAE SSP PNEUMONIAE. THE API 20 E ALSO GAVE A GOOD ID (97.3%) OF K. PNEUMONIAE SSP PNEUMONIAE. THEREFORE, THE FINAL IDENTIFICATION OF THIS ORGANISM IS K. PNEUMONIAE SSP PNEUMONIAE. ISOLATES 911256 AND 911258 (K. PNEUMONIAE): FOR BOTH ISOLATES, ALL CARDS TESTED GAVE AN EXCELLENT ID (98%) OF K. OXYTOCA. HOWEVER, THE API 20 E GAVE A GOOD ID (97.3%) OF K. PNEUMONIAE SSP PNEUMONIAE, SO THE FINAL IDENTIFICATION OF THESE ORGANISMS IS K. PNEUMONIAE SSP PNEUMONIAE. ISOLATE 911257 (K. PNEUMONIAE): BOTH GN CARDS GAVE A VERY GOOD ID - SLASHLINE OF E. CLOACAE COMPLEX. API 20 E ALSO GAVE A GOOD ID (97.7%) OF E. CLOACAE. THEREFORE, THE FINAL IDENTIFICATION OF THIS ORGANISM IS E. CLOACAE. A COMPARISON OF REACTION RESULTS FOR THE CARDS GIVING THE MISIDENTIFICATION OF K. OXYTOCA TO THE EXPECTED REACTION RESULTS FOR K. PNEUMONIAE SSP PNEUMONIAE REVEALED 1 ATYPICAL NEGATIVE REACTION (BXYL) AND 1 ATYPICAL POSITIVE REACTION (5KG) THAT LED TO THE MISIDENTIFICATION. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. BIOMÉRIEUX WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX A DISCREPANT RESULT FOR A BLOOD CULTURE ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER TESTED A GRAM NEGATIVE BACILLI WHICH WAS IDENTIFIED AS KLEBSIELLA OXYTOCA WITH THE VITEK® 2 GN TEST. THE CUSTOMER STATED THAT THEIR OFFLINE TEST FOR INDOLE WAS NEGATIVE WITH THE KLEBSIELLA OXYTOCA ISOLATE AND SHOULD BE POSITIVE. THE ISOLATE WAS CULTURED ON MACCONKEY BLOOD AGAR. REPEAT TESTING PRODUCED THE SAME RESULT. THE CUSTOMER SENT THE KLEBSIELLA OXYTOCA TO A REFERENCE LABORATORY FOR ID CONFIRMATION. THE ISOLATE WAS IDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO THE PATIENT'S HEALTH OR TREATMENT. THE ISOLATE AND TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.