VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 21, 2015
Report 1950204-2015-00038 · MDR key 5090679
Device
Product problems
- Low Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ORGANISM WAS SUBCULTURED, AND TESTING INCLUDED TWO (2) CARDS FROM THE CUSTOMER CARD LOT AND ONE (1) CARD FROM TWO (2) RANDOM LOTS. API® 20NE WAS ALSO PERFORMED. FOR ALL CARDS TESTED, A LOW DISCRIMINATION CALL OF ACINETOBACTER LWOFFII / MORAXELLA GROUP WAS OBTAINED. SINCE ACINETOBACTER LWOFFII IS PRESENTED AS A POSSIBLE ORGANISM, THE RESULTS ARE ACCEPTABLE FOR VITEK® 2 TESTING. FOR THE API® 20NE, A GOOD IDENTIFICATION (B)(4) OF ACINETOBACTER LWOFFII WAS OBTAINED. THE VITEK® 2 GN ID CARDS ARE PERFORMING WITHIN PERFORMANCE SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A DISCREPANT CAP SURVEY ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. ACINETOBACTER LWOFFII WAS MISIDENTIFIED AS METHYLBACTERIUM. AFTER BEING INFORMED OF THE CORRECT ORGANISM IDENTIFICATION, THE TEST WAS REPEATED AND THE CORRECT IDENTIFICATION OF ACINETOBACTER LWOFFII WAS OBTAINED. QC ORGANISM SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER NO LONGER HAS THE CAP ORGANISM; SUBMITTAL IS NOT POSSIBLE. THERE IS NO INDICATION OR REPORT 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. NO PATIENT WAS DIRECTLY ASSOCIATED WITH THE QC RESULT. BIOMERIEUX INVESTIGATION WILL BE INITIATED.