API 20 E
Received Oct 19, 2020
Report 9615754-2020-00163 · MDR key 10697386
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
INVESTIGATION: A BIOMÉRIEUX INTERNAL INVESTIGATION WAS INITIATED IN RESPONSE TO THIS CUSTOMER COMPLAINT OF A MISIDENTIFICATION OF YERSINIA BERCOVIERI AS YERSINIA ENTEROCOLITICA IN ASSOCIATION WITH THE API® 20 E 25STRIPS (REF 20100). THE LOT NUMBER WAS NOT PROVIDED. AS THE LOT NUMBER OF API 20 E STRIP USED IS UNKNOWN AND STRAIN NOT AVAILABLE, THE INVESTIGATION WAS COMPLETED BY ANALYZING THE API DATABASE CONTENT AND BY TESTING STRAINS OF YERSINIA BERCOVIERI AVAILABLE AT BIOMÉRIEUX. API DATABASE: YERSINIA BERCOVIERI IS NOT INCLUDED IS THE API 20 E (REFERENCES 20100 AND 20160) DATABASE. THEREFORE, AN IDENTIFICATION RESULT OF YERSINIA BERCOVIERI IS NOT POSSIBLE WITH THESE PRODUCT REFERENCES. INTERNAL SAMPLES: FOUR (4) BIOMÉRIEUX STRAINS OF YERSINIA BERCOVIERI WERE TESTED WITH THE API 20 E. TWO (2) STRAINS OBTAINED SINGLE CHOICE IDENTIFICATIONS OF YERSINIA ENTEROCOLITICA, ONE (1) STRAIN OBTAINED A LOW DISCRIMINATION IDENTIFICATION WHICH INCLUDED YERSINIA ENTEROCOLITICA, AND ONE (1) STRAIN OBTAINED NO IDENTIFICATION. TESTING OF INTERNAL STRAINS REPRODUCED THE CUSTOMER'S CLAIMED MISIDENTIFICATION. COMPLAINT TREND ANALYSIS: A COMPLAINT TREND ANALYSIS WAS PERFORMED ON PRODUCT REFERENCES 20100 AND 20160 (API 20 E) AND REVIEWED COMPLAINTS SINCE 2017. NO OTHER COMPLAINTS WERE REGISTERED FOR THIS ISSUE. RISK ASSESSMENT: BIOMERIEUX RISK MANAGERS ASSESSED THE SEVERITY OF THE ASSOCIATED HAZARD AS NEGLIGIBLE AND THE OVERALL RISK TO BE IRRELEVANT. CONCLUSION: AS YERSINIA BERCOVIERI IS NOT INCLUDED IN THE API 20 E DATABASE (PRODUCT REFERENCES 20100 AND 20160), ACCURATE IDENTIFICATION IS NOT CURRENTLY POSSIBLE WITH THESE PRODUCT REFERENCES. AS SOME YERSINIA BERCOVIERI STRAINS AVAILABLE AT BIOMÉRIEUX WERE IDENTIFIED TO YERSINIA ENTEROCOLOITICA, A STUDY WILL BE DONE TO EVALUATE THE POSSIBILITY TO INTEGRATE YERSINIA BERCOVIERI IN A FUTURE API 20 E DATABASE UPDATE.
Description of Event or Problem
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF YERSINIA BERCOVIERI AS YERSINIA ENTEROCOLITICA IN ASSOCIATION WITH THE API® 20 E 25STRIPS (REF 20100). THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER STATED THAT THEY OBTAINED A VERY GOOD IDENTIFICATION OF YERSINIA ENTEROCOLITICA. THE STRAIN WAS SENT TO THE INSTITUT PASTEUR WHERE THE IDENTIFICATION WAS DETERMINED TO BE YERSINIA BERCOVIERI VIA MALDI-TOF ANALYSIS. API 20 E: YERSINIA ENTEROCOLITICA, MALDI-TOF: YERSINIA BERCOVIERI. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH.