VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Oct 5, 2015
Report 1950204-2015-00058 · MDR key 5128229
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE CUSTOMER SUBMITTED ONE LAB REPORT FOR THE AGLAE PROFICIENCY SAMPLE; THE SAMPLE IDENTIFICATION WAS ACINETOBACTER BAUMANNII. THE INTENDED RESULT WAS PSEUDOMONAS PUTIDA. THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR A CULTURE SUBMITTAL. NO MICROBIOLOGICAL TESTING IS POSSIBLE. INFORMATION FROM THE AGLAE FINAL REPORT INDICATES THIS STRAIN OF PSEUDOMONAS PUTIDA IS FROM CULTURE COLLECTIONS (B)(4). INFORMATION REGARDING THESE CULTURE COLLECTIONS STATES THE TEMPERATURE AT WHICH THIS STRAIN GROWS WELL IS 26C. THE AGLAE REPORT INDICATES THAT CUSTOMER SUB-CULTURE GROWTH WAS PERFORMED AT 30C. THE TEMPERATURE AT WHICH STRAINS ARE TESTED IN THE VITEK® 2 GN ID CARD IS (B)(4). SINCE THE OPTIMUM TEMPERATURE FOR GROWTH OF THIS STRAIN IS LOWER THAN THAT USED FOR TESTING THE GN ID CARD, THE ORGANISM WAS LIKELY LESS REACTIVE THAN EXPECTED, RESULTING IN AN INCREASED NUMBER OF ATYPICAL REACTIONS LEADING TO THE MIS-IDENTIFICATION. REVIEW OF THE MANUFACTURING QC RECORDS FOR THE GN ID CARD LOT USED BY THE CUSTOMER INDICATES LOT 241336440 PASSED ON THE INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED. THE GN ID CARD LOT PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A DISCREPANT EXTERNAL CONTROL SURVEY ORGANISM IDENTIFICATION ON THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT ((B)(4), LOT 241336440). A PSEUDOMONAS PUTIDA ORGANISM MISIDENTIFIED AS ACINETOBACTER BAUMANII. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER STATED THEY NO LONGER HAVE THE STRAIN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.