VITEK 2 GN TEST KIT

Additional Manufacturer Narrative

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING A PATIENT SAMPLE. THE CUSTOMER REPORTED THE VITEK® 2 GN TEST KIT IDENTIFIED THE ORGANISM AS K. OXYTOCA; HOWEVER, THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE IT WAS IDENTIFIED AS K. PNEUMONIA BY (B)(4). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) VITEK® 2 GN CARDS FROM THE CUSTOMER'S LOT , TWO (2) CARDS FROM A RANDOM LOT AND THE API 20E. ALL VITEK® 2 GN CARDS TESTED RESULTED IN EXCELLENT IDENTIFICATIONS OF KLEBSIELLA PNEUMONIAE. THE API® 20E RESULTED IN A GOOD IDENTIFICATION (5215773) OF KLEBSIELLA PNEUMONIAE. REVIEW OF THE KLEBSIELLA OXYTOCA DATA AGAINST EXPECTED REACTIONS FOR KLEBSIELLA PNEUMONIAE SHOWED TWO (2) ATYPICAL POSITIVE REACTIONS (5KG AND ELLM) ACCORDING TO THE VITEK® 2 GN KNOWLEDGE BASE, CONTRIBUTING TO THE MISIDENTIFICATION. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. THE MOST RECENT QUARTERLY TREND REVIEW DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE. VITEK® 2 GN CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING A PATIENT SAMPLE. THE CUSTOMER REPORTED THE VITEK® 2 GN TEST KIT IDENTIFIED THE ORGANISM AS K. OXYTOCA; HOWEVER, THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE IT WAS IDENTIFIED AS K. PNEUMONIA BY MALDITOF. THE CUSTOMER REPEATED TESTING IN THEIR LAB AND THE RESULTS OF THE RE-RUN WERE K. PNEUMONIA SSP PNEUMONIA. THE CUSTOMER INDICATED THERE WAS NO INJURY TO THE PATIENT, NO INCORRECT TREATMENT AND NO DELAY ASSOCIATED WITH THE MISIDENTIFICATION. CULTURE SUBMITTALS WERE REQUESTED BY BIOMÉRIEUX. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.