MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA

Catalog Number 10300

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

Intended use: api® listeria is a qualitative standardized system for the identification of listeria.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.The complete list of those organisms that it is possible to identify with this system is given in the technical brochure - information for identification software.Issue description: an industry customer from france notified biomérieux of unacceptable profile result obtained with listeria monocytogenes in association with api listeria 10strips+10media - 10300, lot.1009868240, exp date: 11/24/2023).A related complaint (b)(4) was created to document the same issue obtained by the same customer, same product but different lot number.Results are summarized below: api listeria -ref:10300-(lots : 009868240 and 1010042770) matrix: customer 1: butter and raw fresh tomme cheese matrix customer 2 eil reyma: milk powder: samples (b)(6).Maldi-tof verification: profile matches listeria monocytogenes for all 6 strains.Customer reported that on several galleries of the above-mentioned batches, they obtained profile 6531 which gives an "unacceptable profile" result.Identification were done with 2 different technicians on 2 different batches.After several tests, they obtained listeria monocytogenes profiles, but this was random.Doubting the results, customer produced several galleries (different batches) for the same strain which caused delayed results.At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to any customer's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context: an industry customer from france notified biomérieux of unacceptable profile result obtained with listeria monocytogenes in association with api listeria 10strips+10media - 10300, lot.1009868240, exp date: 11/24/2023).A related complaint (b)(4) was created to document the same issue obtained by the same customer, same product but different lot number: 1010042770.Results are summarized below: api listeria -ref:(b)(4)lots : 009868240 and 1010042770).Matrix: customer 1: butter and raw fresh tomme cheese matrix customer 2 eil reyma: milk powder: samples (b)(6).Maldi-tof verification: profile matches listeria monocytogenes for all 6 strains.Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results a review of the production and quality control data for the two batches did not reveal any defects or anomalies that might explain the problem encountered.Tests carried out according to quality control protocol on samples of both batches comply with biomérieux specifications.The performance of these batches is therefore not called into question.Summary of investigation results: - the identification of 2 strains returned by the customer were confirmed as listeria monocytogenes by vitek ms.- the 2 strains returned by the customer were tested on api listeria strips : lot 1010042770 related to the complaint and lot blister 1010160290 (finish product 1010160300) used as reference lot.The lot number 1009868240 also related to complaint can not be tested because this lot was expired.The 2 strains tested gave a good identification to listeria monocytogenes on the 2 api listeria lots tested (profil 6510).The difference between the customer results and the investigation results concerned the rib and tag tests which were obtained positive by the customer while they are expected negative for a listeria monocytogenes strain.Conclusion: - no non conformities registered during manufacturing and quality control processes for the 2 lot numbers related to the complaints (lots 1009868240 and 1010042770).- no product performance issue detected during qc investigation on the 2 lots related to the complaints (lots 1009868240 and 1010042770) by using the 3 qc strains included in the package insert.- customer issue not reproduced during investigation tests by using the 2 strains returned by the customer on the lot number 1010042770 related to the complaint (lot number 1009868240 not tested because expired when investigation tests were performed).

• Brand Name: API LISTERIA 10STRIPS+10MEDIA
• Type of Device: API LISTERIA 10STRIPS+10MEDIA
• 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: céline lacroix gimon ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17903255
• MDR Text Key: 325247336
• Report Number: 9615754-2023-00041
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Catalogue Number: 10300
• Device Lot Number: 1009868240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1