VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 8, 2015
Report 1950204-2015-00025 · MDR key 5062023
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH A CAP SURVEY ORGANISM (D-08 ACINETOBACTER LWOFFII) AND THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD). THE ORGANISM WAS REPORTED AS ACINETOBACTER BAUMANII BY THE HOSPITAL LABORATORY. THIS RESULT WAS OBTAINED BY THE CUSTOMER USING TWO (2) DIFFERENT CARD LOTS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED USING THE SAME CAP SURVEY ORGANISM FROM INTERNAL STOCK. THE ORGANISM WAS SUBCULTURED, AND TESTING INCLUDED ONE (1) GN ID CARD FROM EACH CUSTOMER LOT AND ONE (1) CARD FROM TWO (2) RANDOM LOTS. API® 20NE WAS ALSO PERFORMED. FOR ONE (1) OF THE CUSTOMER LOTS (241337120) AND THE TWO (2) RANDOM LOTS, 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 OTHER CUSTOMER LOT (241344640), AN IDENTIFICATION OF MORAXELLA GROUP WAS OBTAINED. THE API 20NE GAVE A GOOD IDENTIFICATION (B)(4) OF A. LWOFFII . DUE TO THE DUPLICATION OF THE CUSTOMER RESULT FOR GN ID CARD LOT 241344640, EVALUATION OF MANUFACTURING AND QC BATCH RECORDS WAS PERFORMED. THE EVALUATION INDICATED THE LOT PASSED ON INITIAL TESTING AND PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER RECEIVED CAP RESULTS WHERE ISOLATE SHOULD HAVE BEEN IDENTIFIED AS ACINETOBACTER IWOFFII HOWEVER, RESULTS FROM VITEK 2 GN ID TEST KIT, (REF (B)(4)) WERE IDENTIFIED AS ACINETOBACTER BAUMANII 99% TWO TIMES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. LAB REPORTS AND ISOLATE SUBMITTAL HAVE BEEN REQUESTED FROM THE CUSTOMER. BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.