VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Jan 7, 2016
Report 1950204-2016-00002 · MDR key 5351203
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. INVESTIGATIONAL TESTING INCLUDED: VITEK 2 GN ID (CUSTOMER LOT): LOW DISCRIMINATION PASTEURELLA MULTOCIDA/CANIS. VITEK 2 GN ID (RANDOM LOT): LOW DISCRIMINATION PASTEURELLA MULTOCIDA/CANIS. VITEK MS: IDENTIFICATION TO PASTEURELLA MULTOCIDA. THE 16S SEQUENCING: IDENTIFICATION TO PASTEURELLA MULTOCIDA. ID32E STRIP: IDENTIFICATION TO PASTEURELLA MULTOCIDA. THE INVESTIGATION DID NOT REPRODUCE THE DISCREPANT RESULTS REPORTED BY THE CUSTOMER. THE INVESTIGATION CONCLUDED THAT THE VITEK 2 GN ID CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) DISCREPANT RESULTS FOR A PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK (TM) 2 GRAM-NEGATIVE (GN) ID TEST KIT. ON SEPARATE TESTS, THE ISOLATE WAS IDENTIFIED AS ESCHERICHIA COLI AND PASTEURELLA MULTOCIDA. THE CUSTOMER DID NOT INDICATE THAT ANY CONFIRMATORY TESTING WAS PERFORMED VIA AN ALTERNATE METHOD. THE CUSTOMER DID NOT INDICATE WHICH RESULT, IF EITHER, WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.