VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

EXEMPTION NUMBER E2015048 - THIS MDR IS PART OF THE 227 PILOT PROGRAM. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED FOR PATIENT ISOLATES RECEIVED FROM EACH CUSTOMER FOR EVENTS 1 - 5. INVESTIGATION FOR EVENT #6 IS PENDING. EVENTS #1 & 2: IN EACH CASE, A REFERENCE METHOD IDENTIFIED AN ORGANISM THAT IS NOT CLAIMED IN THE VITEK® 2 GRAM NEGATIVE KNOWLEDGE BASE. 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." IN ADDITION, FOR EVENT #2, THE CUSTOMER DID NOT FOLLOW INSTRUCTIONS FOR USE WITH RESPECT TO CULTURE INCUBATION TIME. EVENT #3: THE PATIENT ISOLATE WAS SUBMITTED TO BIOMÉRIEUX AND INVESTIGATION WAS CONDUCTED. THE INVESTIGATION SHOWED AN INABILITY TO OBTAIN A CONSISTENT IDENTIFICATION RESULT REGARDLESS THE TEST METHOD USED: 16S SEQUENCING, API 50CHE, ID 32E STRIPS, VITEK MS, OR VITEK 2 GN ID CARD (CUSTOMER LOT AND RANDOM LOT). THE INVESTIGATION CONCLUDED THE PATIENT ISOLATE IS AN ATYPICAL ORGANISM FOR ALL METHODS TESTED. EVENT #4: THE CORRECT ORGANISM IDENTIFICATION OF CITROBACTER FREUNDII WAS OBTAINED VIA VITEK® 2 GN ID TEST KIT (CUSTOMER LOT AND RANDOM LOT). THE INVESTIGATION DID NOT DUPLICATE THE MISIDENTIFICATION OBTAINED BY THE CUSTOMER AS SHIGELLA GROUP. EVENT #5: THE PATIENT ISOLATE WAS SENT TO A REFERENCE LABORATORY WHICH WAS UNABLE TO IDENTIFY THE ORGANISM VIA ALTERNATE RAPID TEST METHOD. THE INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATE IS AN ATYPICAL STRAIN FOR VITEK® 2 SYSTEM PHENOTYPIC RAPID AST TESTING METHOD. METHODS SUCH AS API® AND DISC DIFFUSION ARE MORE CONDUCIVE TO TESTING ORGANISMS EXHIBITING SLOW-GROWTH BEHAVIOR. THE INVESTIGATIONS CONCLUDED THE VITEK® 2 GN ID CARD IS PERFORMING AS INTENDED AND WITHIN THE SCOPE OF PRODUCT SPECIFICATIONS. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TESTING VIA THE VITEK® 2 GRAM NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT RESULTED IN ORGANISM MISIDENTIFICATIONS. MISIDENTIFICATION OF NON-SALMONELLA ISOLATE AS SALMONELLA. MISIDENTIFICATION OF ROSEOMONAS ROSEA. MISIDENTIFICATION OF ENTEROBACTER CLOACAE AS SERRATIA PLYMUTHICA. MISIDENTIFICATION OF CITROBACTER FREUNDII AS SHIGELLA GROUP. MISIDENTIFICATION OF GRAM NEGATIVE ROD, LACTOSE POSITIVE AS PSEUDOMONAS LUTEOLA. MISIDENTIFICATION OF CITROBACTER WORKMANII AS CITROBACTER FARMERI. ALL OF THE EVENTS INVOLVED PATIENT ORGANISM IDENTIFICATION TEST RESULTS. NONE OF THE EVENTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS AND RAW TEST DATA WERE REQUESTED FOR EACH EVENT.