MAUDE Adverse Event Report: BIOMERIEUX, SA API 20 E 25STRIPS

Catalog Number 20100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: api® 20 e is a qualitative standardized system for the identification of enterobacteriaceae and other non-fastidious gram-negative rods.It uses miniaturized tests as well as a specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.Description of the issue.A customer in (b)(6) notified biomérieux of obtaining an identification of salmonella while the tested sample was "simulated 10g carcass ¿ escherichia coli + pseudomonas aeruginosa" during external quality control test using the product api 20 e (ref 20100, lot#1008123340).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation in response to a customer complaint of the misidentification of escherichia coli and pseudomonas aeruginosa as salmonella in association with the api® 20 e test strip (ref.20100, lot 1008123340) when performing a comparison study.The customer stated that the impacted strains were not available to submit for investigation.Review of lot 1008123340 production records found that no non-conformity was recorded.Biomérieux reviewed complaints for misidentifications associated with ref.20100 and for complaints associated with lot 1008123340; neither review identified a trend.A study was performed by using the knowledge base (kb) api 20 e to compare the results the customer obtained with the percentage of the tests in the kb for escherichia coli and pseudomonas aeruginosa.The results of the study of biochemical profiles indicate that the profile obtained was not related to a mixture of escherichia coli and pseudomonas aeruginosa strains included in the sample.The investigation identified potential causes of the misidentification were: - a contamination of the suspension by another strain, - an error during the realization of the suspension by using another strain to inoculate the strip, - the colony identified was a salmonella spp.

• Brand Name: API 20 E 25STRIPS
• Type of Device: API 20 E 25STRIPS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12301728
• MDR Text Key: 283086920
• Report Number: 9615754-2021-00224
• Device Sequence Number: 1
• Product Code: JSS
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20100
• Device Lot Number: 1008123340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1