NUCLISENS? MAGNETIC EXTRACTION REAGENTS 200293

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-30 for NUCLISENS? MAGNETIC EXTRACTION REAGENTS 200293 manufactured by Biom?rieux Sa.

Event Text Entries

[63660683] A customer in the netherlands contacted biom? Rieux 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. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5

[73818973] An internal biom? Rieux 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.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3002769706-2016-00531
• MDR Report Key: 6215908
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2016-12-30
• Date of Report: 2017-04-10
• Date Mfgr Received: 2017-03-14
• Date Added to Maude: 2016-12-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ELLEN WELTMER
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: ST. LOUIS MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer G1: BIOM
• Manufacturer Street: 5, RUE DES BERGES
• Manufacturer City: GRENOBLE CEDEX 01, FR 38024
• Manufacturer Country: FR
• Manufacturer Postal Code: 38024
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: Z-2342-2016
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NUCLISENS? MAGNETIC EXTRACTION REAGENTS
• Generic Name: NUCLISENS? MAGNETIC EXTRACTION REAGENTS
• Product Code: JJH
• Date Received: 2016-12-30
• Catalog Number: 200293
• Lot Number: 16072701
• Device Expiration Date: 2017-08-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOM?RIEUX SA
• Manufacturer Address: 5, RUE DES BERGES GRENOBLE CEDEX 01, FR 38024 FR 38024

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-12-30