VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 2, 2016
Report 1950204-2016-00116 · MDR key 5924156
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
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA SONNEI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. IT IS UNKNOWN WHAT METHOD OF TESTING WAS PERFORMED TO CONFIRM THE RESULT AS ESCHERICHIA COLI. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS WERE REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
A CUSTOMER IN BELGIUM CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA SONNEI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER DID NOT SUBMIT A LAB REPORT FOR THE ESCHERICHIA COLI IDENTIFICATION. IT HAS BEEN DETERMINED THE CUSTOMER WAS NOT USING VALIDATED MEDIA (MH). THIS IS THE SECOND COMPLAINT FROM THIS CUSTOMER FOR MIS-IDENTIFICATION OF ESCHERICHIA COLI INVOLVING NON-VALIDATED MEDIA (KLIGLER AND MH). TWO (2) LAB REPORTS WERE SUBMITTED SHOWING EXCELLENT IDENTIFICATION OF SHIGELLA SONNEI. REVIEW OF THE ATYPICAL REACTIONS DID NOT REVEAL ANY ACCORDING TO THE GN KNOWLEDGE BASE. HOWEVER, THE HOUR OF CALL WAS EARLY 4.75 HOURS AND MANY REACTIONS ARE NOT FINALIZED AT THAT POINT. E. COLI IS CLOSELY RELATED TO SHIGELLA. ANY IDENTIFICATION OF SHIGELLA SHOULD BE CONFIRMED WITH ANOTHER METHOD SUCH AS SEROLOGY. THE GN LAB REPORT PRINTS THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS" FOR ANY IDENTIFICATION OF SHIGELLA. IN THIS CASE, USE OF NON-VALIDATED MEDIA FOR TESTING MAY HAVE CONTRIBUTED TO THE MIS-IDENTIFICATION OF THE ISOLATE. NO FURTHER ACTION REQUIRED.