API® 20 NE
Received Dec 19, 2018
Report 3002769706-2018-00254 · MDR key 8179424
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INTERNAL INVESTIGATION WAS PERFORMED FOR A MISIDENTIFICATION IN ASSOCIATION WITH THE API® 20 NE (NON-ENTEROBACTERIACEAE) TEST STRIPS (LOT 1006179400). THE CUSTOMER REPORTED OBTAINING PSEUDOMONAS FLUORESCENS WITH API 20 NE AND PSEUDOMONAS CHLORORAPHIS BY SEQUENCING. COMPLAINTS TREND ANALYSIS: THERE IS NO OTHER COMPLAINT FOR API® 20 NE RELATED TO A MISIDENTIFICATION OF A PSEUDOMONAS CHLORORAPHIS STRAIN. INSTRUCTION FOR USE ANALYSIS: THE ISSUE ENCOUNTERED BY THE CUSTOMER IS INDICATED IN THE LIMITATIONS SECTION IN THE INSTRUCTION FOR USE. THE API 20 NE SYSTEM IS INTENDED UNIQUELY FOR THE IDENTIFICATION OF THOSE NON-FASTIDIOUS, NON-ENTERIC GRAM-NEGATIVE RODS INCLUDED IN THE DATABASE. IT CANNOT BE USED TO IDENTIFY ANY OTHER MICROORGANISMS OR EXCLUDE THEIR PRESENCE. PSEUDOMONAS CHLORORAPHIS AND PSEUDOMONAS FLUORESCENS ARE VERY CLOSE. THIS IS WHY THE RESULT OBTAINED IS PSEUDOMONAS FLUORESCENS. TEN (10) PSEUDOMONAS CHLORORORAPHIS STRAINS WERE TESTED ON THE API 20 NE AND NINE (9) OF THEM THE RESULT OBTAINED WAS PSEUDOMONAS FLUORESCENS. IN CONCLUSION, THE PRODUCT WORKS AS EXPECTED AND THE LIMITATION FOR SPECIES NOT PRESENT IN THE DATABASE IS PRESENT ON THE INSTRUCTIONS FOR USE.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION IN ASSOCIATION WITH THE API® 20 NE (NON-ENTEROBACTERIACEAE) TEST STRIPS (LOT 1006179400). THE CUSTOMER TESTED THE STRAIN FROM A 24 HOUR CULTURE ON TSA, WITH THE API NE, AND THE INITIAL IDENTIFICATION WAS PSEUDOMONAS CEPACIA (68.9%). THE CUSTOMER REPEATED THE TEST WITH AN INCUBATION OF 48 HOURS AT 33 ° C, AND OBTAINED PSEUDOMONAS FLUORESCENS (97.2%). THE CUSTOMER SENT THE STRAIN TO ANOTHER LABORATORY FOR PCR AND THE RESULT WAS PSEUDOMONAS CHLORORAPHIS. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.