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

A customer in france notified biomérieux of contamination when testing with nuclisens® nucl.Magn.Silica 384t (ref.(b)(4), lot #z012nc1ms, expiry date: 28-dec-2022) with patient samples.The original complaint from this customer (cn-(b)(6), mdr # 3008249922-2022-00002-00) seemed to be related to a contamination issue caused by the nuclisens® extr.Buffer 3(4x1l) ref.(b)(4).However, during the investigation of the issue it was discovered that the client received impacted lots of nuclisens magnetic silica.Therefore, this case was opened to document the impacted lot that belongs to the scope of the fsca 5690.The customer noticed some false positive results: the negative extraction controls gave bands, while the negative amplification controls were negative.The analysis of the sequence found directed the customer towards an environmental bacterium.The customer did not deliver any false positive results but this issue lead to a delay in reporting results.The length of the delay is not known but it was noted that it was a long time.In the meantime, the customer has been performing the extractions manually.

Manufacturer Narrative

A biomérieux internal investigation has been completed 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 (b)(4)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 (b)(6)2022 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.

• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15237161
• MDR Text Key: 304782565
• Report Number: 3008249922-2022-00022
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/16/2022

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: 12/28/2022
• Device Catalogue Number: 280133
• Device Lot Number: Z012NC1MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/16/2022
• 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
• Removal/Correction Number: FSCA 5690
• Patient Sequence Number: 1