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

Catalog Number 280133

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from united kingdom notified biomérieux of legionella contamination of nuclisens® magnetic silica (ref.280133 ) leading to a false positive result when testing patient sample on emag (ref.418591, serial number: (b)(4).Indeed the customer obtained two (2) positive results when testing patient samples.The two positive patient results were questioned, and the customer investigated by performing a new extraction on easymag.The negative control on this run came up positive.This established there was a potential problem beyond the patients and with at least one of the customer¿s machines.The customer performed decontamination process and investigated the source of contamination (easymag, emag and reagents).The issue of legionella contamination was apparent on all molecular platforms.The user has three easymags in one lab that share pipettes; however, the emag in another lab on its own also had the issue.Due to this issue, the customer was able to continue testing for legionella pneumophila; however, screening for legionella species is suspended until this issue is resolved.The customer informed biomérieux on 25-may-2022 that the issue impacted two patients before legionella species screening was suspended.Wrong results were reported to physician (the results were not specified).The customer indicated that patients were potentially treated incorrectly; however, a consultant bacteriologist intervention may have prevented treatment changing for patients.It is to be noted that in the instructions for use it is written : ¿to ensure the proper proceedings of the extraction, always use the appropriate controls to control the extraction procedure: a positive extraction control (sample/material positive to the target).A negative extraction control (sample/material negative to the target).An internal control (ic): obtained by transferring a fixed quantity of target control in each sample to extract.The internal control must be added before the isolation steps to be purified along with the target, and then be amplified and/or detected.An internal control is necessary for any application that can lead to false negative results.¿ as of 02-jun-2022, the source of the contamination was identified as nuclisens® magnetic silica (ref.280133).The lots of nuclisens® magnetic silica (ref.280133) used by the customer were not specified.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An update was received from the customer on 05-aug-2022 confirming that, in entirety, there were only two patients affected by this issue at their site and one lot impacted of nuclisens® easymag® magnetic silica (lot z012me1ms).Additionally, the customer was able to confirm that no serious injury occurred for these two patients.No actual treatment was administered to the patients as the lab system controls functioned correctly.The patient samples were recollected, leading to a delay in results.There was no adverse event related to either patient's state of health due to the delay or initial discrepant result.This report is updated accordingly.A biomérieux internal investigation has been completed, following notification from multiple customers of contamination, with the following results: the investigation confirmed the contamination issue.It was done on retained kits from 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.Tests have been done to define if the source of the contamination was from viable bacteria or traces of nucleic acids.The contamination is essentially nucleic acid contamination; however, low environmental bacteria contamination have been also observed.Note that the nuclisens extraction reagents are not sterile nor claimed dna rna free, so a residual background signal could be expected.Investigation results highlighted that three (3) raw materials from one of our supplier are impacted by the issue.It corresponds to 15 different biomérieux finished product ref 280133 batches (list of batches: z012me1ms, z012mf1ms, z012mh1ms, z012mk1ms, z012ml1ms, z012mg1ms, z012ne1ms, z012nd1ms, z012nc1ms, z012nb1ms, z013af1ms, z013ag1ms, z013ah1ms, z013ak1ms, z013al1ms).All these batches were blocked with a product stop shipment and a field safety notice, fsca 5690, was issued on 01jul2022 to inform our customers of the issue and of the actions required.The final risk identified was the inability to render a result, or having delayed results, according to the fact that a negative extraction control must be used in extraction run.The investigation confirmed that there is no safety risk for users.All other silica raw materials corresponding to silica batches currently on the field have been tested and are not impacted by the issue.Performances of all impacted silica batches have been verified on viral parameters and other applications than bacterial ones and did show that there was no impact using them.All applications for which the negative extraction control is valid, i.E.Negative, in downstream application, can be exploitable.Nevertheless, batches verified by r&d investigation to be not concerned by the contamination issue were sent as replacement for customers performing bacterial nucleic acids amplification.A capa with an investigation at supplier level has been opened, and while awaiting the outcome, biomerieux has put additional testing in place to secure any new batch release.Section b1 - adverse event/product problem updated from "adverse event" to "product problem".Section h1 - type of reportable event updated from "serious injury" to "malfunction" health effect - clinical code and health effect - impact code were updated.

• 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): BIOMÉRIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer Contact: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14713053
• MDR Text Key: 295028591
• Report Number: 3008249922-2022-00012
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 280133
• Device Lot Number: Z012ME1MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: FSCA 5690
• Patient Sequence Number: 1