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) 2022, a customer from netherlands notified biomérieux of mycobacterium genus contamination of nuclisens® magnetic silica 384t (ref.280133, lot number z013ae1ms, expiration date: 28 jan 2023) leading to a false result when testing patient sample.The customer reported contamination in the extraction negative control during mycobacterium genus testing.The negative control samples used to check the extraction are presenting positive signal.This issue impacted patients and wrong results were reported to physician (the results were not specified).At the time of this assessment, there is no information regarding any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was performed following notification from a customer in netherlands of mycobacterium genus contamination of nuclisens® magnetic silica 384t (ref.280133, lot number z013ae1ms, expiration date: 28 jan 2023.The investigation confirmed that this lot was not contaminated.A contamination issue was confirmed with specific lots of nuclisens magnetic silica, for which fsca 5690 was issued.However, the silica lot involved in this instance, z013ae1ms, is not part of the listed impacted lots in fsca 5690.Testing was done on retained kits from the manufacturing site and also on raw material for batches currently released on the field at that time.The investigation demonstrated that the contamination comes from silica raw material from a supplier.The silica raw material produced internally are not impacted by the issue.List of incriminated lots: z012me1ms, z012mf1ms, z012mh1ms, z012mk1ms, z012ml1ms, z012mg1ms, z012ne1ms, z012nd1ms, z012nc1ms, z012nb1ms, z013af1ms, z013ag1ms, z013ah1ms, z013ak1ms, z013al1ms).All other batches have been tested by the investigation r&d team.These lots, including the lot involved in this complaint, were conforming and not concerned by the contamination issue.In addition, no more contamination has been observed using these other silica batches by some complaint customers on incriminated batches.Some customers may have observed contamination with these uncontaminated silica lots due to: - a difference of sensitivity in the pcr test compared to tests done by investigation r&d team.- a residual environmental contamination in customer lab.- or possibly the use of pooled batches within contaminated ones.(pooling is not part of good practices).For these customers, the recommendation is to discard all opened reagents, (ic, silica.), to perform a decontamination of the lab and to run contamination/blank tests after.

• 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 berges; grenoble 38024 ; FR 38024
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14898290
• MDR Text Key: 303743557
• Report Number: 3008249922-2022-00019
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 280133
• Device Lot Number: Z013AE1MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1