NUCLISENS? MAGNETIC SILICA 280133

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 2016-08-19 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.

Event Text Entries

[52496418] An internal biom? Rieux investigation was conducted. Results are as follows: a difference of quantification up to 1 log and sometime more than 1 log was observed , which can be significant on results. As the downstream applications are qualitative and/or quantitative methods, the decrease in 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. During the investigation, we confirmed the issue for the following specific customer's applications: 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 (<40kbp) and medium genome sizes (to 1200kbp). The root cause has not yet been identified. The investigation is still ongoing internally. Single stranded rna virus applications are not impacted excepted if the rna is extracted without matrix (e. G. In water). No significant impact has been identified for the ivd nuclisens and argene real time pcr kits validated with the easymag and the minimag extraction systems. As stated in the easymag user manual, 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 to 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

[52496419] A customer reported a discrepant result when using the nuclisens magnetic silica reagent. The internal control of the eluate did not pass the required customer criteria. When specifically asked, the customer indicated that no death, injury or mistreatment was associated with this issue. The customer did indicate a delay of results of 1 day as a result of needing to rerun the samples.
Patient Sequence No: 1, Text Type: D, B5

[61323730] A customer reported a discrepant result when using the nuclisens? Magnetic silica reagent. An internal biom? Rieux investigation was conducted. A difference of quantification up to 1 log and sometime more than 1 log was observed , which can be significant on results. As the downstream applications are qualitative and/or quantitative methods, the decrease in 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. During the investigation, we confirmed the issue for the following specific customer's applications: impact when using a high sample input volume, from 200ul and up to 1 ml. Impact when double stranded nucleic acid applications with small (<40kbp) and medium genome sizes (to 1200kbp). The root cause has not yet been identified. The investigation is still ongoing internally. Single stranded rna virus applications are not impacted excepted if the rna is extracted without matrix (e. G. In water). No significant impact has been identified for the ivd nuclisens and argene real time pcr kits validated with the easymag? And the minimag? Extraction systems. As stated in the easymag? User manual, the use of an internal control is recommended in order to detect any potential nucleic acid extraction issue. The design of the internal control has to be as close as possible to the requested target's design in order to be 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: 3002769706-2016-00143
• MDR Report Key: 5888337
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2016-08-19
• Date of Report: 2016-07-21
• Date Mfgr Received: 2016-07-21
• Date Added to Maude: 2016-08-19
• 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: MRS. ELLEN WELTMER
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3147317301
• 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
• Remedial Action: NO
• Previous Use Code: 3
• Removal Correction Number: FSCA 3037
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NUCLISENS? MAGNETIC SILICA
• Generic Name: NUCLISENS? MAGNETIC SILICA
• Product Code: LDT
• Date Received: 2016-08-19
• Catalog Number: 280133
• Lot Number: Z017DB1MS
• Device Expiration Date: 2017-04-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• 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	1. Hospitalization	2016-08-19