MAUDE Adverse Event Report: BIOMERIEUX, SA API® 20 NE

Catalog Number	20050
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
Event or Problem Description
A customer in (b)(6) reported a misidentification in association with the api® 20 ne (non-enterobacteriaceae) test strips (lot 1006179400).The customer tested the strain from a 24 hour culture on tsa, with the api ne, and the initial identification was pseudomonas cepacia (68.9%).The customer repeated the test with an incubation of 48 hours at 33 ° c, and obtained pseudomonas fluorescens (97.2%).The customer sent the strain to another laboratory for pcr and the result was pseudomonas chlororaphis.No patient information was provided by the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a misidentification in association with the api® 20 ne (non-enterobacteriaceae) test strips (lot 1006179400).The customer reported obtaining pseudomonas fluorescens with api 20 ne and pseudomonas chlororaphis by sequencing.Complaints trend analysis: there is no other complaint for api® 20 ne related to a misidentification of a pseudomonas chlororaphis strain.Instruction for use analysis: the issue encountered by the customer is indicated in the limitations section in the instruction for use.The api 20 ne system is intended uniquely for the identification of those non-fastidious, non-enteric gram-negative rods included in the database.It cannot be used to identify any other microorganisms or exclude their presence.Pseudomonas chlororaphis and pseudomonas fluorescens are very close.This is why the result obtained is pseudomonas fluorescens.Ten (10) pseudomonas chlorororaphis strains were tested on the api 20 ne and nine (9) of them the result obtained was pseudomonas fluorescens.In conclusion, the product works as expected and the limitation for species not present in the database is present on the instructions for use.

• Brand Name: API® 20 NE
• Common Device Name: API® 20 NE
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8179424
• Report Number: 3002769706-2018-00254
• Device Sequence Number: 16567901
• Product Code: JSS
• UDI-Device Identifier: 03573026047702
• UDI-Public: 03573026047702
• 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): 02/19/2019

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: 11/23/2018
• Device Catalogue Number: 20050
• Device Lot Number: 1006179400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1