API 20 E 25STRIPS
Received Feb 10, 2021
Report 9615754-2021-00014 · MDR key 11308773
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
A CLIENT FROM (B)(6) NOTIFIED BIOM¿RIEUX OF A MISIDENTIFICATION OF LELLIOTTIA AMNIGENA (ENTEROBACTER AMNIGENUS) AS PANTOEA WHILE TESTING AN AGLAE PROFICIENCY SAMPLE WITH THE API¿ 20 E STRIP (REF. 20100, LOT NUMBER 1008041520). AN ALTERNATIVE TEST METHOD (MALDI IDENTIFICATION) WAS PERFORMED AND OBTAINED AN ORGANISM IDENTIFICATION TO LELLIOTTIA AMNIGENA. AS THIS WAS AN AGLAE PROFICIENCY SAMPLE, THERE IS NO PATIENT INVOLVED. A BIOM¿RIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING A MISIDENTIFICATION OF LELLIOTTIA AMNIGENA (ENTEROBACTER AMNIGENUS) AS PANTOEA WHILE TESTING AN AGLAE PROFICIENCY SAMPLE WITH THE API® 20 E STRIP (REF. (B)(4), LOT NUMBER 1008041520). THE REVIEW OF PRODUCTION AND QUALITY CONTROL DATA FOR BATCH 1008041520 DID NOT INDICATE ANY DEFECTS OR ANOMALIES WHICH COULD EXPLAIN THE MISIDENTIFICATION OF THE ENTEROBACTER AMNIGENUS GERM AS PANTOEA SPP. THE TESTS PERFORMED USING BIOMERIEUX¿S SAMPLE LIBRARY OF BATCH 1008041520 COMPLIED WITH SPECIFICATIONS, AND WITH THE DATA OBTAINED DURING THE RELEASE OF THE BATCH. THE TESTS PERFORMED ON THE CUSTOMER¿S STRAIN DID NOT CONFIRM THE CUSTOMER IDENTIFICATION OF PANTOEA SPP. THE EXPECTED IDENTIFICATION OF ENTEROBACTER AMNIGENUS WAS OBTAINED. THE MISIDENTIFICATION TO PANTOEA SPP OBTAINED BY THE CUSTOMER WAS NOT REPRODUCED INTERNALLY. THE CUSTOMER¿S ISSUE WAS NOT CONFIRMED; THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTION IS NECESSARY.