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

Model Number 10300

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

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

Event Type  malfunction  

Event Description

An industry customer in (b)(6) notified biomérieux of obtaining a misidentification result in association with the api® listeria 10 strips +10media (ref.10300, lot 1008988000).The customer stated lot 1008988000 did not identify the industry strain.The isolate was also tested on the vitek® 2 which identified the strain as listeria monocytogenes.Biomérieux customer service reviewed the provided lab reports and observed non-reactive/low reactivity on the sugar wells.The customer then tested the atcc® l.Monocytogenes isolate with lots 1008988000, 1008506770, and 1008452670 incubated in two separate incubators at 35°c and 37°c.The same "no identification" results were obtained.Refer to 9615754-2021-00301 and 9615754-2022-00005 for lots 1008452670 and 1008506770, respectively.As there is no patient associated with these industry and quality control strains, there is no adverse impact to any patient¿s state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

An industry customer in singapore notified biomérieux of obtaining misidentification results in association with the api® listeria test (ref.(b)(4), lot 1008988000).Review of the batch records for api listeria (ref.(b)(4); lot# 1008452670, 1008988000 and 1008506770), did not highlight any anomalies during manufacturing or quality control which could lead to an identification issue.There is neither trend of complaints on the batches 1008452670, 1008988000 and 1008506770, nor on product reference (b)(4) regarding the issue reported.The quality control strains tested (listeria monocytogenes atcc® 19115¿ and atcc® 7644¿) on the retained sample of the batch impacted (batch 1008988000) complied with specifications.The customer confirmed (07th january 2022) that this issue was not reproduced during retesting at their laboratory with the atcc® 7644¿ strain, using batch 1008988000.The biomérieux complaint investigation laboratory was also unable to determine or confirm a root cause for this customer¿s issue.Biomérieux customer service reminded the customer of the lab protocol for misidentification or no identification issues with api listeria and/or difficulties to interpret: - check the purity of the strains tested before carrying out any identification with api listeria strips, - perform the tests with fresh strains (24 hours), - follow strictly the protocol described on the instruction for use, - respect the validated delay of storage of reagents after opening, - follow the recommendations in the iso 11133 standard regarding the conservation, preparation and subculture of collection strains (such as atcc strains).

• Brand Name: API LISTERIA 10STRIPS+10MEDIA
• Type of Device: API LISTERIA 10STRIPS+10MEDIA
• Manufacturer (Section D): BIOMÉRIEUX 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 strauel ; 5, rue des aqueducs; craponne, MO 69290 ; FR 69290
• MDR Report Key: 13308113
• MDR Text Key: 284355742
• Report Number: 9615754-2022-00016
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2022
• Device Model Number: 10300
• Device Catalogue Number: 10300
• Device Lot Number: 1008988000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1