VITEK® 2 GN TEST KIT
Received Nov 24, 2015 · Event occurred Nov 16, 2015
Report 1950204-2015-00106 · MDR key 5245941
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2015, A CUSTOMER REPORTED TO BIOMERIEUX AN INCIDENT THAT THE VITEK 2 GN TEST KIT OBTAINED THE WRONG IDENTIFICATION COMPARED TO OTHER METHODOLOGIES. THE VITEK 2 TEST DETERMINED THE IDENTIFICATION TO BE PSEUDO LUTEOLA WHEREAS OTHER METHOD DETERMINED IT TO BE PSEUDO AERUGINOSA. THERE IS NO INDICATION FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION INTO THIS INCIDENT HAS BEEN INITIATED WITHIN BIOMERIEUX.
Additional Manufacturer Narrative
BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ISOLATES (2) WERE SUBCULTURED AND TESTING INCLUDED THE FOLLOWING. ISOLATE 1: GN ID CARD FROM THE SAME LOT AS THAT TESTED BY THE CUSTOMER - VERY GOOD IDENTIFICATION CALLS OF KLEB PNEUMONIAE SSP OZAENAE. GN ID CARD FROM A RANDOM LOT - VERY GOOD IDENTIFICATION CALLS OF KLEB PNEUMONIAE SSP OZAENAE. API® 20E - LOW DISCRIMINATION CALL BETWEEN ENT CLOACAE (54.9%) AND KLEB PNEUMONIAE (31.5%). A 16S SEQUENCING - IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. VITEK® MS - IDENTIFICATION AS KLEBSIELLA PNEUMONIAE. ISOLATE 2: GN ID CARD FROM THE SAME LOT AS THAT TESTED BY THE CUSTOMER - UNIDENTIFIED ORGANISM. GN ID CARD FROM A RANDOM LOT - IDENTIFICATION OF PANTOEA AGGLOMERANS. API® 20E - DOUBTFUL PROFILE WITH THE CHOICES INCLUDING KLEBSIELLA PNEUMONIAE (27.2%) / PANTOEA 1(18.5%) / PSEUDOMONAS LUTEOLA (18.4%) / PANTOEA 3 (18.4%). A 16S SEQUENCING - KLEBSIELLA PNEUMONIAE. REVIEW OF THE PANTOEA DATA AGAINST THE EXPECTED REACTIONS FOR KLEBSIELLA PNEUMONIAE SHOW THE PANTOEA DATA TO HAVE 19 ATYPICAL NEGATIVE REACTIONS. THIS BEHAVIOR SUGGESTS VERY SLOW ORGANISM GROWTH WHICH IS NOT CONDUCIVE TO PHENOTYPIC AST TESTING METHODS. BOTH 16S SEQUENCING AND VITEK® MS USE GENETIC MEASUREMENT TECHNIQUES AND ARE MORE CONDUCIVE TO TESTING CERTAIN SLOWER-GROWTH ORGANISMS. THE INVESTIGATION DID NOT REPRODUCE THE CUSTOMER'S IDENTIFICATION OF PSEUDOMONAS LUTEOLA. THE VITEK® 2 GN ID CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.