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

Intended use: the nuclisens® easymag® accessory products are reagents and disposables to be used with the biomérieux instruments which mention these products in their user manuals.They enable the automated extraction (purification and concentration) of total nucleic acids (rna/dna) from homogeneous human biological fluid samples.These products are intended for in vitro diagnostic use by healthcare professionals.Description of the issue: on (b)(6) 2022, a customer in canada notified biomérieux of bacterial contamination when using nuclisens® magnetic silica (ref.280133, lot#: z012mf1ms, expiry date: 28-nov-2022).The customer observed bacterial contamination with one of his easymag instruments.The customer did a thorough and deep decontamination.16s pcr was done and the contamination still remained.However, the size of the amplicons was a bit bigger than the usual 16s obtained from various bacteria.The customer had the amplicon sequenced but no definitive answer as to what organism he is dealing with.According the customer no patient results was affected and no wrong result was given to the physician.The customer reported that there was no patient harm or incorrect treatment due to the referenced issue.However, the customer reported unexpected delay but the length of the delay is unknown at this stage of the assessment.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

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.Note: initially, two complaints were opened for the same issue for each of the customer's two instruments, (cn-357222 and cn-357232).However, the investigation revealed that it was the silica (nuclisens magnetic silica ref.280133) from the supplier that was impacted.The customer used the same silica lot on both instruments.Therefore, this case (b)(6) / mdr 3008249922-2022-00017 is a duplicate from the case (b)(6) / 3008249922-2022-00016.

• 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: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14754341
• MDR Text Key: 303158676
• Report Number: 3008249922-2022-00017
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 280133
• Device Lot Number: Z012MF1MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• 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: Initial
• Patient Sequence Number: 1