VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT MISIDENTIFIED AN NON-SHIGELLA ORGANISM AS SHIGELLA SONNEI. UPON OBTAINING SHIGELLA IDENTIFICATION, THE CUSTOMER SENT ISOLATES TO THE STATE LAB FOR CONFIRMATORY TESTING; RESULTS WERE RETURNED AS "NOT CONSISTENT WITH SHIGELLA SPECIES." SHIGELLA RESULTS WERE REPORTED ON PATIENT INITIALLY AND CORRECTED RESULTS WERE CALLED TO PHYSICIAN. AS THE CUSTOMER QUESTIONED THE PURITY OF THE CULTURE, REPEAT VITEK 2 GN ID TESTING WAS PERFORMED FOLLOWING PERFORMANCE OF IMPROVED LABORATORY PRACTICES. REPEAT TESTING INDICATED NO EVIDENCE OF SHIGELLA IN THE SPECIMEN.. BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX REQUEST FOR SUBMITTAL OF PATIENT ISOLATE, RAW TEST DATA OR LAB REPORTS. INFORMATION CONCERNING THE ACTUAL SPECIES OF THE STRAIN THAT MISIDENTIFIED WAS NOT AVAILABLE; ONLY THAT IT WAS NON-SHIGELLA. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, THE CUSTOMER INDICATED THEY HAD NOT AUTOCLAVED THEIR DISPENSETTE. AFTER AUTOCLAVING THEIR DISPENSETTE, THE CUSTOMER INDICATED THAT THE ISSUE WAS DUE TO THEIR USE OF CULTURES THAT WERE NOT PURE. EVALUATION OF THE MANUFACTURING QC BATCH RECORDS FOR GN ID CARD LOT 241354940 INDICATED THAT THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. THE INVESTIGATION CONCLUDED THE VITEK® 2 GN ID CARD IS PERFORMING AS INTENDED.