VITEK® 2 GN ID TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT INCONSISTENT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. FOR THE SAME STRAIN, INITIAL RESULT WAS AEROMONAS HYDROPHILIA/CAVIAE AND REPEAT TEST OBTAINED AEROMONAS SOBRIA. 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 HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER IN SAUDI ARABIA CONTACTED BIOMÉRIEUX TO REPORT INCONSISTENT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER SUBMITTED THE ISOLATES FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED. THE TWO SUBMITTED ISOLATES WERE SUBCULTURED AND GN CARD TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS ON TWO CARDS FROM EACH OF THE IMPLICATED LOTS AND TWO CARDS FROM A RANDOM LOT. API 20NE WAS ALSO PERFORMED. ISOLATE 911267 (01BC1639369): FIVE OF THE SIX GN CARDS TESTED, RESULTED IN EXCELLENT IDENTIFICATIONS OF AEROMONAS SOBRIA. THE REMAINING CARD GAVE A LOW DISCRIMINATION IDENTIFICATION OF AEROMONAS HYDROPHILA/CAVIAE/SOBRIA. THE API20NE RESULTED IN A VERY GOOD IDENTIFICATION 99% AEROMONAS SOBRIA. FOR THIS ISOLATE, THE MISIDENTIFICATION WAS NOT REPRODUCED AND CARDS ARE PERFORMING AS EXPECTED. ISOLATE 911268 (01BC1643526): FOUR OF THE SIX GN CARDS TESTED RESULTED IN EXCELLENT IDENTIFICATIONS OF AEROMONAS SOBRIA. THE REMAINING TWO CARDS, BOTH FROM LOT 241379410, RESULTED IN EXCELLENT IDENTIFICATIONS OF AEROMONAS HYDROPHILA/CAVIAE, REPRODUCING THE CUSTOMER'S RESULTS. THE API20NE RESULTED IN A VERY GOOD IDENTIFICATION 99% AEROMONAS SOBRIA. THESE SPECIES ARE CLOSELY RELATED. REVIEW OF THE AEROMONAS HYDROPHILA/CAVIAE DATA AGAINST EXPECTED REACTIONS FOR AEROMONAS SOBRIA DEMONSTRATED ONE ATYPICAL POSITIVE REACTION (GGT) CONTRIBUTING TO THE MISIDENTIFICATION. A REVIEW OF QUALITY RECORDS CONFIRMED GN LOTS 241379410 AND 241386540 BOTH MET THE CRITERIA FOR QC PERFORMANCE TESTING AND FINAL RELEASE. IN CONCLUSION, A MISIDENTIFICATION FOR ONE ISOLATE WAS NOT REPRODUCED AND THE SECOND ISOLATE WAS AN ATYPICAL STRAIN. THE VITEK® 2 GN CARDS PERFORMED AS INTENDED.