MAUDE Adverse Event Report: BIOMÉRIEUX, SA API 20 NE 25STRIPS+25MEDIA - 20050

Model Number	20050
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product intended use: api® 20 ne is a qualitative standardized system for the identification of non-fastidious, non-enteric gram-negative rods (for example, pseudomonas, acinetobacter, moraxella, vibrio, aeromonas).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 from (b)(6) reported that he obtained a misidentification of pseudomonas fragi as pseudomonas putida when using api 20 ne strip (ref.(b)(4)) ¿ lot 1008507190.The customer reported he identified a strain with api, maldi (bruker) and pcr and he obtained the following results: api 20 ne: pseudomonas putida (99.1%, after 24 and 48h), maldi and pcr: pseudomonas fragi.To be noted that pseudomonas fragi is not included in the api database.There is no indication from the customer that this issue led to a delay of result or impacted the patient state of health.
Additional Manufacturer Narrative
A customer from germany reported that he obtained a misidentification of pseudomonas fragi as pseudomonas putida when using api® 20 ne strip (ref.20050/ lot 1008507190).Investigation: review of the complaint database from january 2018 indicated there have been no other complaints reported against this lot for this kind of issue.Review of the batch history record for the customer¿s lot (1008507190) revealed there were no anomalies nor non-conformities noted during the manufacture, quality control, or packaging processes.(b)(4) kits of the batch number 1008507190 were released on 4th february 2021.Retained sample testing: the quality control procedure was performed on the batch 1008507190, by comparison to a reference lot (api 20 ne 25 strips+25 media).The following strains (documented in the instruction for use 07615 l) were tested : aeromonas hydrophila atcc® 35654¿; alcaligenes faecalis ssp faecalis atcc® 35655¿; sphingobacterium multivorum atcc® 35656¿; and pseudomonas aeruginosa atcc® 27853¿.The results obtained with these four strains are compliant to the specifications indicated in the package insert 07615 l.For each strain, there are no differences between the results obtained with the two (2) batches tested.The performance of the lot# 1008507190 is compliant with specifications and consistent with the other lots tested.Conclusion: the species pseudomonas fragi is currently not included in the database api 20 ne, thus it is not possible to identify this species with api 20 ne strips.A study was performed previously to evaluate the possibility to include the species pseudomonas fragi in the api 20 ne database.The outcome of the study indicated it is not possible to update the database with this species.

• Brand Name: API 20 NE 25STRIPS+25MEDIA - 20050
• Common Device Name: API 20 NE 25STRIPS+25MEDIA - 20050
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12342699
• Report Number: 9615754-2021-00227
• Device Sequence Number: 3938731
• Product Code: JSS
• UDI-Device Identifier: 03573026047702
• UDI-Public: 03573026047702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 12/23/2021
• Device Model Number: 20050
• Device Catalogue Number: 20050
• Device Lot Number: 1008507190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown