VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT DISCREPANT ORGANISM IDENTIFICATIONS IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE GN LOT TESTED WITH THE MISIDENTIFICATION: 241330040. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED. THE RESULTS ARE AS FOLLOWS: CUSTOMER RESULTS: THE LAB REPORT SHOWED SEVEN (7) ATYPICAL REACTIONS FOR S. MALTOPHILIA (4 ATYPICAL NEGATIVE; 3 ATYPICAL POSITIVE) ACCORDING TO THE GN KNOWLEDGE BASE (NEGATIVE = BGLU, LIP, PHOS, GGAA AND POSITIVE = DCEL, AGLTP, DGLU). NO INFORMATION WAS AVAILABLE REGARDING THE CUSTOMER'S SET UP PROCEDURE. INVESTIGATION CONCLUSION: AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE THE FOLLOWING: CONTAMINATION; MIXED CULTURE; USE OF NON-RECOMMENDED MEDIA; USER SET UP ERRORS; AN ATYPICAL STRAIN. IN CONCLUSION, A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. INITIAL QC PERFORMANCE TESTING WAS REVIEWED FOR VITEK® 2 GRAM-NEGATIVE (GN) ID TEST KIT LOT 241330040. THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. WITHOUT THE STRAIN OR RAW DATA, IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. NO FURTHER ACTIONS DEEMED NECESSARY.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED DUE TO VITEK 2 GN ID MISIDENTIFICATION OF A GRAM-NEGATIVE ROD AS ACINETOBACTER BAUMANNII. SUBSEQUENT TESTING AT THE CUSTOMER SITE BY THE BIOMÉRIEUX ACCOUNT SPECIALIST INDICATED THE STRAIN WAS PROTEUS MIRABILIS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. REVIEW OF THE LAB REPORT ASSOCIATED WITH THE PATIENT ISOLATE SHOWED TEN (10) ATYPICAL REACTIONS (6 ATYPICAL NEGATIVE, 4 ATYPICAL POSITIVE) FOR PROTEUS MIRABILIS ACCORDING TO THE GN ID KNOWLEDGE BASE (NEGATIVE = H2S, ODC, GGAA, DTRE, GGT, PHOS AND POSITIVE = AGLTP, DMNE, LHISA, MNT). AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET-UP ERROR, OR AN ATYPICAL STRAIN. EVALUATION OF THE MANUFACTURING QC RECORDS FOR GN ID LOT 241322240 INDICATES THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED. AS THE GN ID CARD LOT USED AT THE CUSTOMER SITE HAD EXPIRED AT THE TIME OF INVESTIGATION, TWO RANDOM LOTS WERE USED FOR INVESTIGATIONAL PURPOSES. BOTH LOTS OBTAINED EXCELLENT IDENTIFICATION CALLS OF PROTEUS MIRABILIS. API 20E PROVIDED A RESULT OF PROTEUS MIRABILIS WITH A 99.9% CONFIDENCE LEVEL, CONFIRMING THE VITEK 2 RESULT TO BE CORRECT. THE INVESTIGATION DID NOT REPRODUCE THE MISIDENTIFICATION OBSERVED BY THE CUSTOMER. THE INVESTIGATION CONCLUDED THE VITEK 2 GN ID CARD IS PERFORMING AS EXPECTED.

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 VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE ISOLATE WAS SENT TO A REFERENCE LABORATORY (B)(4) FOR CONFIRMATORY TESTING. INITIAL CUSTOMER ID: (B)(6). REPEAT TEST: PROTEUS MIRABILIS, (B)(4) ID: ESCHERICHIA COLI. 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. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.