VITEK® 2 GN ID TEST KIT
Received Nov 10, 2016
Report 1950204-2016-00171 · MDR key 6092583
Device
Generic name
Vitek® 2 Gn Id Test Kit
Manufacturer
Biomerieux, IncCatalog number
21341
Lot number
241376140
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
AN INVESTIGATION WAS CONDUCTED FOR A MISIDENTIFICATION OF PASTEURELLA MULTOCIDA AS BURKHOLDERIA PSEUDOMALLEI WHEN TESTED WITH THE VITEK® 2 GN CARD LOT 241376140. THE CUSTOMER REPORTED TESTING WITH THE GN CARD WAS PERFORMED USING A SAMPLE DIRECTLY FROM A BLOOD CULTURE BOTTLE. THIS IS OFF LABEL USE. THE GN KNOWLEDGE BASE DOES NOT SUPPORT TESTING OF ISOLATES DIRECTLY FROM SPECIMENS SUCH AS BLOOD CULTURE BOTTLES. NO FURTHER ANALYSIS PERFORMED. A REVIEW OF QUALITY RECORDS SHOWED GN LOT 241376140 MET FINAL RELEASE CRITERIA, AND THERE WERE NO ISSUES DURING INITIAL QC PERFORMANCE TESTING. THE INVESTIGATION CONCLUDED THE MISIDENTIFICATION WAS CAUSED FROM OFF LABEL USE BY THE CUSTOMER.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF PASTEURELLA MULTOCIDA AS BURKHOLDERIA PSEUDOMALLEI IN ASSOCIATION WITH THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER PERFORMED ALTERNATE TESTING METHODS (BRUKER MALDI-TOF AND 16S SEQUENCING); BOTH METHODS OBTAINED IDENTIFICATION TO PASTEURELLA MULTOCIDA. THEREFORE, BURKHOLDERIA WAS EXCLUDED AS A POSSIBLE ID. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS BY BIOMERIEUX FOR INTERNAL INVESTIGATION. BIOMERIEUX INVESTIGATION WILL BE INITIATED.