MAUDE Adverse Event Report: BIOMERIEUX, 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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: API 20 E
• Common Device Name: API® 20 E
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10697386
• Report Number: 9615754-2020-00163
• Device Sequence Number: 11527621
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 10/19/2020

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 Catalogue Number: 20100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1