MAUDE Adverse Event Report: BIOMÉRIEUX SA API 20 E; API® 20 E

Catalog Number	20100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) has notified biomérieux of obtaining a misidentification of lelliottia amnigena (enterobacter amnigenus) as pantoea while testing an aglae proficiency sample with the api® 20 e 25strips (ref 20100, lot 1007955490).Maldi-tof testing was performed as an alternative method and obtained an identification of lelliottia amnigena.Global customer service (gcs) confirmed that lelliottia amnigena is known as enterobacter amnigenus in the api® technical library and can be identified by api® 20 e strips.Gcs reviewed the data provided by the customer and identified that the customer obtained several atypical negative test results and an atypical positive result for an identification of lelliottia amnigena.As this was an aglae proficiency sample, there is no patient involved.A biomérieux 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 algae proficiency sample with the api® 20 e 25strips (ref 20100, lot 1007955490).The review of production and quality control data for batch 1007955490 did not indicate any defects or anomalies which could explain the misidentification of the enterobacter amnigenus germ as pantoea spp.The tests performed on biomerieux¿s sample library of batch 1007955490 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's 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.

• Brand Name: API 20 E
• Common Device Name: API® 20 E
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11208414
• Report Number: 9615754-2021-00010
• Device Sequence Number: 11606211
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: 20100
• Device Lot Number: 1007955490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1