VITEK® 2 GN TEST KIT
Received Jan 6, 2017
Report 1950204-2017-00005 · MDR key 6230884
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
Description of Event or Problem
A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS KLEBSIELLA OXYTOCA (99%) IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE ISOLATE WAS TESTED WITH THE FILMARRAY® AND WAS IDENTIFIED AS KLEBSIELLA PNEUMONIA, WHILE TESTING WITH THE VITEK®2 GN IDENTIFIED KLEBSIELLA OXYTOCA. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO THE PATIENT. THE ISOLATE WAS REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION CONCLUDED THE FOLLOWING: THE SUBMITTED ISOLATE WAS SUBCULTURED AND TESTING INCLUDED GN CARDS FROM THE CUSTOMER'S LOT AND A RANDOM LOT, IN DUPLICATE. ALSO TESTED WAS THE API 20E TEST KIT. ALL FOUR GN CARDS TESTED RESULTED IN EXCELLENT IDENTIFICATIONS OF KLEBSIELLA PNEUMONIAE. THE API 20E GAVE A LOW DISCRIMINATION IDENTIFICATION OF K. PNEUMONIAE 1/ K. PNEUMONIAE 2. VITEK 2 GN CARDS ARE PERFORMING AS EXPECTED. A REVIEW OF THE CUSTOMER'S K. OXYTOCA DATA (ANALYSIS TIME OF 2 HOURS) AGAINST THE EXPECTED REACTIONS FOR K. PNEUMONIAE DEMONSTRATED 1 ATYPICAL POSITIVE REACTION (IARL) CONTRIBUTING TO THE MISIDENTIFICATION.