MAUDE Adverse Event Report: BIOMÉRIEUX SA NUCLISENS® MAGNETIC EXTRACTION REAGENTS

Catalog Number 200293

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the netherlands contacted biomérieux to report discrepant results with nuclisens magnetic extraction reagent product involving a recovery issue with the silica.The customer, an industry food laboratory that follows iso 15216 for virus detection in food, uses a bib process control of a similar virus that they want to detect and this similar virus is spiked (b)(6)sample.The customer reported a difference with respect to the internal quality control between the recalled batch (identified as "bad batch")and the new batch (identified as "good batch) as follows: (b)(6).The customer indicated a shift of about (b)(6) between the good and bad batches.Indicating that with a low amount of virus in their sample they could have encountered (b)(6) results.The customer indicated the target virus as (b)(6) , extraction of rna from (b)(6) of each food sample using an appropriate guanidine thiocyanate disruption and silica absorption-based method.The internal control was indicated as a process control virus stock similar to the virus to detect.The customer confirmed not receiving false results only lower recovery.There is no patient involved in this event, because the customer is an industry (non-clinical customer).There is no indication or report from the laboratory that the discrepant result led to any adverse event.Biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was conducted.Results are as follows: a difference of quantification up to 1 log and sometimes more than 1 log was observed.As the downstream applications are qualitative and/or quantitative, the decrease of performances in downstream application could lead to: a risk of false negative for qualitative tests, invalid results when extracted and amplified internal control is not within specifications, under-quantification for viral load results for quantitative tests we have confirmed the issue for the following customer's application specificity: impact when using a high sample input volume, from 200 l and up to 1 ml.Impact when double stranded nucleic acid applications with small (<40 kbp) and medium genome sizes (to 1200 kbp).Single stranded rna virus applications were not impacted, excepted if rna was extracted without matrix (e.G.In water).This part of the investigation was carried out on a panel of worst case downstream applications but cannot guarantee to cover all customers application techniques.No significant impact has been highlighted for the ivd nuclisens easyq and argene real time pcr kits validated with the nuclisens easymag and minimag extraction systems.The root cause has been identified on raw material production from a supplier.The use of these recent lot numbers of magnetic silica (magsil) has solved the issue.In parallel to the release of new silica batches, the shelf life /stability of those batches were verified in order to confirm that no degradation of quality performance.As mentioned in the easymag user manuel, the use of an internal control is recommended in order to detect potential nucleic acid extraction issue.The design of the internal control has to be as close as possible of the requested target's design in order to be the more efficient.A field safety corrective action (fsca) 3037 has been issued to impacted subsidiaries/distributors to notify affected customers of this issue.

• Brand Name: NUCLISENS® MAGNETIC EXTRACTION REAGENTS
• Type of Device: NUCLISENS® MAGNETIC EXTRACTION REAGENTS
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des berges; grenoble cedex 01, fr 38024 ; FR 38024
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des berges; grenoble cedex 01, fr 38024 ; FR 38024
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6215908
• MDR Text Key: 63660683
• Report Number: 3002769706-2016-00531
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 200293
• Device Lot Number: 16072701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: Z-2342-2016
• Patient Sequence Number: 1