VITEK 2 GN TEST KIT

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING A PERI-PANCREATIC ABSCESS SWAB FROM A PATIENT. THE CUSTOMER REPORTED THE VITEK® 2 GN TEST KIT IDENTIFIED THE ORGANISM AS KLEBSIELLA PNEUMONIAE. THIS RESULT WAS COMMUNICATED TO THE PHYSICIAN. THE ISOLATE WAS SENT TO A REFERENCE LAB WHERE IT WAS IDENTIFIED AS ENTEROBACTER AEROGENES. THE PHYSICIAN INDICATED THERE WAS NO EVIDENCE THE FALSE IDENTIFICATION LED TO A NEGATIVE INFLUENCE ON PATIENT TREATMENT. AN INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A MISIDENTIFICATION OF ENTEROBACTER AEROGENES AS KLEBSIELLA PNEUMONIA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD). THE CUSTOMER SUBMITTED THREE (3) PATIENT ISOLATES (S1, S2, S3) FOR INVESTIGATIONAL TESTING. INVESTIGATIONAL TESTING INCLUDED: VITEK® MS: CONFIRMED ORGANISM IDENTIFICATION OF ENTEROBACTER AEROGENES FOR S1, S2 AND S3. ID32E: - S1 AND S2 OBTAINED LOW-DISCRIMINATION CALLS. - S3 OBTAINED ORGANISM ID OF ENTEROBACTER AEROGENES. VITEK® 2 GN ID (CUSTOMER LOT AND RANDOM LOT): - S1 PROVIDED LOW-DISCRIMINATION CALL (INCLUDED ENTEROBACTER AEROGENES) FOR THE CUSTOMER LOT, AND OBTAINED A RESULT OF ENTEROBACTER AEROGENES FOR THE RANDOM LOT. - S2 WAS LOW-DISCRIMINATION (INCLUDED ENTEROBACTER AEROGENES) FOR BOTH LOTS. - S3 WAS MISIDENTIFIED TO THE SPECIES KLEBSIELLA PNEUMONIAE FOR BOTH LOTS. THE INVESTIGATION CONCLUDED ALL THREE (3) SUBMITTED ISOLATES HAVE AN ATYPICAL BIOCHEMICAL PROFILE; THERE IS NO EVIDENCE TO SUGGEST THE VITEK® 2 GN ID CARD IS PERFORMING OUTSIDE OF SPECIFICATIONS.