VITEK 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT (REF (B)(4), LOT 241325840). THE ORGANISM WAS REPORTED AS PSEUDOMONAS LUTEOLA; CONFIRMED BY DUPLICATE TESTING. THE PATIENT ISOLATE WAS SENT TO ARIZONA REFERENCE LAB FOR CONFIRMATORY TESTING; THE REFERENCE LAB IDENTIFIED THE ISOLATE AS PSEUDOMONAS LUTEOLA USING VITEK® 2 METHODS. FURTHER TESTING BY AN ADDITIONAL REFERENCE LABORATORY ((B)(4)) REPORTED A PRESUMPTIVE ID OF YERSINIA PESTIS/PSEUDOTUBERCULOSIS. TESTING TIMELINE: PATIENT ARRIVED IN EMERGENCY ROOM (DATE NOT PROVIDED) IN SEVERE PAIN AND WAS SENT TO SURGERY WHERE AN AXILLARY REGION WAS SWABBED AND SENT TO THE HOSPITAL LABORATORY FOR ROUTINE ANALYSIS. SAMPLE WAS SUB-CULTURED TO MAC, CHOC, AND TSAB AGAR. GRAM STAIN: GRAM NEGATIVE RODS. (B)(6) 2015, THEY PERFORMED TESTING VIA VITEK® 2 GN ID CARD, LOT 241325840. GN ID CARD EXCELLENT ID 96% PS. LUTEOLA. RESULT OF PSEUDOMONAS LUTEOLA REPORTED TO PHYSICIAN. (B)(6) 2015, THEY REPEATED THE GN ID CARD LOT 241325840. GN CARD EXCELLENT ID 99% PSEUDOMONAS LUTEOLA. (B)(6) 2015 - PATIENT ISOLATE WAS SENT TO (B)(6) REFERENCE LAB FOR CONFIRMATORY TESTING. (B)(6) 2015 - REPORT RETURNED FROM REFERENCE LAB WITH ID OF PSEUDOMONAS LUTEOLA. IDENTIFICATION WAS OBTAINED FROM A VITEK® 2. THE LABORATORY STAFF AT (B)(6) WAS CONCERNED THIS WAS NOT A CORRECT IDENTIFICATION, SO THEY REQUESTED THE (B)(6) REFERENCE LAB SEND THE PATIENT ISOLATE TO ANOTHER REFERENCE LAB. (B)(6) 2015 - PATIENT ISOLATE WAS SENT TO (B)(6) WHERE GENE SEQUENCING WAS PERFORMED. (B)(6) 2015 - REFERENCE LAB IN (B)(4) CONTACTED (B)(6) WITH PRESUMPTIVE ID OF Y. PESTIS/PSEUDOTUBERCULOSIS. (B)(6) 2015 - (B)(6) LAB PROCESSED THE PATIENT ISOLATE ON VITEK® 2 USING TWO DIFFERENT LOTS OF GN ID CARD. LOT 241337540 - EXCELLENT ID 96% PS LUTEOLA. LOT 241332140 - LOW DISCRIMINATION Y. PSEUDOTUBERCULOSIS / Y. PESTIS. THEY PERFORMED A UREASE TEST TO DIFFERENTIATE; THE RESULT WAS NEGATIVE, SO THE ISOLATE WAS CALLED Y. PESTIS. EVALUATION OF THE GROWTH WELL REACTIONS ON THE PATIENT LAB REPORTS FOR THE TWO RESULTS INDICATES A DIFFERENCE FOR ONLY THE BGAL REACTION. THE PATIENT'S CONDITION WAS NOT IMPROVING AT (B)(6) ON ANTIBIOTIC THERAPY BEING GIVEN FOR P. LUTEOLA IDENTIFICATION, AND HE WAS TRANSFERRED TO A DIFFERENT FACILITY; NO FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION WAS PROVIDED FOLLOWING TRANSFER. THE PATIENT WAS DISCHARGED AFTER SEVERAL DAYS AT THE NEW FACILITY. DISCHARGE OCCURRED BEFORE CORRECT IDENTIFICATION OF Y. PESTIS WAS OBTAINED. THE PATIENT WAS SUBSEQUENTLY LOCATED AND PRESCRIBED TREATMENT APPROPRIATE FOR Y. PESTIS DIAGNOSIS. AS YERSINIA PESTIS SPECIES IS CATEGORIZED BSL-3, SUBMITTAL OF THE ISOLATE TO BIOMÉRIEUX IS NOT POSSIBLE. INVESTIGATION BY BIOMÉRIEUX IS IN PROCESS TO DETERMINE POTENTIAL ROOT CAUSE OF THE OCCURRENCE.

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

RAW TEST KIT DATA AND LAB REPORTS ASSOCIATED WITH THE DISCREPANT ORGANISM IDENTIFICATION WERE SUBMITTED BY THE CUSTOMER. ONE OF FOUR GN CARDS TESTED BY THE CUSTOMER GAVE A LOW DISCRIMINATION RESULT BETWEEN YERSINIA PESTIS AND YERSINIA PSEUDOTUBERCULOSIS. THREE OF FOUR GN CARDS TESTED BY THE CUSTOMER GAVE AN IDENTIFICATION OF PSEUDOMONAS LUTEOLA. THE FOLLOWING WELL REACTIONS WERE ATYPICAL WHEN COMPARED TO EXPECTED REACTIONS FOR YERSINIA PESTIS: FOR TWO GN CARDS: BGAL, OFF, DMAL. FOR ONE GN CARD: LLATA. A REVIEW OF THE DATA GRAPHS FOR THE ATYPICAL REACTIONS DID NOT DEMONSTRATE ANY UNUSUAL GROWTH PATTERNS. THE VITEK 2 PRODUCT INFORMATION MANUAL STATES THE FOLLOWING FOR GRAM-NEGATIVE IDENTIFICATION: "NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." THE INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATE IS AN ATYPICAL STRAIN FOR THE VITEK 2 SYSTEM ID TESTING METHOD. THE STRAIN WILL BE FORWARDED TO BIOMÉRIEUX R&D MICROBIOLOGY FOR CONSIDERATION IN FUTURE IDENTIFICATION (ID) DEVELOPMENT ACTIVITIES.