VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Dec 8, 2015
Report 1950204-2015-00117 · MDR key 5274814
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR SAMPLE SUBMITTAL. THE CUSTOMER PROVIDED THREE (3) VITEK® 2 GN ID LAB REPORTS. THE LAB REPORTS INDICATED 15-18 ATYPICAL NEGATIVE REACTIONS WHEN COMPARED TO THE REACTIONS EXPECTED FOR THE ORGANISM (CITROBACTER BRAAKII). THE CUSTOMER STATED THEY ARE UNABLE TO CALIBRATE THE DENSICHEK TM BECAUSE THEY ARE UNABLE TO OBTAIN THE STANDARDS FROM THEIR DISTRIBUTOR. THE DENSICHEK TM IS USED DURING VITEK® 2 GN ID TEST SETUP TO ESTABLISH THE INOCULUM DENSITY OF THE SAMPLE BEING TESTED. AN INCREASE IN ATYPICAL NEGATIVE REACTIONS IS USUALLY DUE TO 1) A SETUP ERROR SUCH AS TOO LIGHT OF AN INOCULUM, 2) STRAIN THAT IS NOT VIABLE, OR 3) OUT OF RANGE FOR AQE-OF-CULTURE ACCORDING TO THE GN ID PRODUCT INFORMATION. SINCE THE CUSTOMER WAS UNABLE TO CALIBRATE THEIR DENSICHEK TM AND ALL OTHER SETUP PARAMETERS MET THE CULTURE REQUIREMENTS ACCORDING TO THE CUSTOMER, IT'S PROBABLE THAT THE INOCULUM WAS TOO LIGHT AND CAUSED THE SIGNIFICANT NUMBER OF ATYPICAL NEGATIVE REACTIONS THAT RESULTED IN A MISIDENTIFICATION OF (B)(6). EVALUATION OF THE MANUFACTURING QC RECORDS INDICATES GN LOT 241338640 PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED. THE GN ID CARD LOT IS PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. VITEK 2 GN ID RESULT - ESCHERICHIA COLI. BRUKER MASS SPEC (MALDI-TOF) - CITROBACTER BRAAKII0 IT IS NOT KNOWN WHICH, IF EITHER, RESULT WAS REPORTED TO THE TREATING PHYSICIAN. HOWEVER, 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 THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. STRAINS WERE DESTROYED BY THE CUSTOMER AND ARE THEREFORE NOT AVAILABLE FOR SUBMITTAL. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.