MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-19 for NUCLISENS? EASYMAG? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[55050681]
Patient Sequence No: 1, Text Type: N, H10
[55050682]
A customer in the united states contacted biom? Rieux to report purity of dna after extraction is discrepant in association with the nuclisens? Easymag? Magnetic silica product. The target is dsdna cystic fibrosis. The sample volume is 200ul. The customer stated they have been unable to report patient results in two weeks. The purity of dna reported by the customer after extracting with the easymag? Is 0. 96 - 1. 3; the customer requires the purity to be from 1. 5 to 2. 5. The ratio of absorbance at 260 nm and 280 nm is used to assess the purity of dna and rna. A ratio of ~1. 8 is generally accepted as "pure" for dna; a ratio of ~2. 0 is generally accepted as "pure" for rna. If the ratio is appreciably lower in either case, it may indicate the presence of protein, phenol or other contaminants that absorb strongly at or near 280 nm. " the customer used a different lot of magnetic silica; no further issues have been observed. There is no indication or report from the laboratory or treating physician that the discrepant result led to any adverse event related to any patient's state of health. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[61216044]
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 200? L and up to 1 ml. Impact when double stranded nucleic acid applications with small (<40kbp) and medium genome sizes (
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00341 |
| MDR Report Key | 5959856 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-22 |
| Date Mfgr Received | 2016-08-22 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2016-09-19 |
| 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 |
| Brand Name | NUCLISENS? EASYMAG? MAGNETIC SILICA |
| Generic Name | NUCLISENS? EASYMAG? MAGNETIC SILICA |
| Product Code | LDT |
| Date Received | 2016-09-19 |
| Catalog Number | 280133 |
| Lot Number | Z017BE1MS |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-19 |