MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® EASYMAG® MAGNETIC SILICA

Catalog Number 280133

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer in netherlands notified biomérieux of observing a contamination with legionella when using nucl.Magn.Silica 384t (ref.280133, lot number z013ce1ms, (b)(6) 2023).The customer observed bacterial contamination on an emag instrument.The customer identified the contamination because several testing runs demonstrated anomalous curves with a flat line, with cp between 30 and 35.This issue led to a delay in rendering results of 1 day because the customer performed tests on duplicate.There is no indication or report from the laboratory that the issue led to adverse event related to any patient's state of health.This silica batch and raw material were checked for contamination prior to release, including a 16s pcr and a legionella pcr qc test performed on silica batches.The customer was instructed to perform decontamination/ emag decontamination and testing verification.At the time of the assessment, no information was provided regarding completion of or results from customer decontamination protocol.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from netherlands that they obtained a contamination with nucl.Magn.Silica 384t (ref.(b)(4), lot number z013ce1ms).Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.Investigation results: the concerned silica batch was produced and released with appropriate controls to monitor the nucleic acids background after the fsca (b)(4), following manufacturing contamination issue on nuclisens® magnetic silica.The lot z013ce1ms was conform.The customer used another silica lot produced with the same raw material as the z013ce1ms, and no issue was obtained with it.The customer performed internal troubleshooting and this action has solved the contamination issue.Good extraction practices and how to perform decontamination and decontamination tests were shared with the customer this issue was considered as an isolated event at the customer site.

• Brand Name: NUCLISENS® EASYMAG® MAGNETIC SILICA
• Type of Device: NUCLISENS® EASYMAG® MAGNETIC SILICA
• Manufacturer (Section D): BIOMERIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer (Section G): BIOMERIEUX SA; 5 rue des belges; grenoble 38024 ; FR 38024
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueduc; craponne 69290 ; FR 69290
• MDR Report Key: 16455116
• MDR Text Key: 310380311
• Report Number: 3008249922-2023-00002
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: C1 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: 05/30/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 280133
• Device Lot Number: Z013CE1MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1