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

Catalog Number 280133

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a performance problem with nuclisens® magnetic silica (lot z018gb1ms).The customer reported experiencing inhibition/ low recovery of internal controls (pdv and phhv viruses) on three easymag® systems.They noticed higher cts on their internal controls.Decontamination provided no improvement.The customer indicated that the silica batch pipets differently than usual.The customer uses the generic extraction protocol stool specific a.Sample types tested are mainly stool, but also swabs and sputa.The customer stated that reported patients results were possibly affected as results with decreased sensitivities were produced during this period of time.The customer stated that sometimes there was an unexpected delay in reporting results because several runs were repeated due to the decreased sensitivity.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the netherlands reported a performance problem with nuclisens® magnetic silica (lot z018gb1ms).The customer submitted the silica for evaluation.An investigation was performed.Real time stabilities were performed on several downstream applications for rna (flu, hiv, mengovirus) and dna (bk) for the impacted nucl.Magn.Silica 384t_ ref 280133_ batch z018gb1ms.All the results conformed to the acceptance criteria and there were no performance issues.The customer's returned silica was tested to exclude any issue related to the shipment or to the storage of the kits.Experiments were performed using the same lots of lysis and extraction buffers as the customer.Three batches of nucl.Magn.Silica 384t_ ref 280133 were compared to the customer batch z018gb1ms.No significant difference was seen and all the results were in accordance to internal specifications.Further investigation could not be performed as the customer's testing conditions could not be reproduced.There was no performance issue with the nuclisens magnetic silica lot z018gb1ms.

• Brand Name: NUCLISENS MAGNETIC SILICA
• Type of Device: NUCLISENS® MAGNETIC SILICA
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des berges; grenoble cedex 01, 38024 ; FR 38024
• MDR Report Key: 7339176
• MDR Text Key: 102914960
• Report Number: 3002769706-2018-00040
• Device Sequence Number: 0
• Product Code: PPM
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 280133
• Device Lot Number: Z018GB1MS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1