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 2016-07-20 for NUCLISENS? EASYMAG? MAGNETIC SILICA 384T 280133 manufactured by Biom?rieux Sa.
[49984277]
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 (
Patient Sequence No: 1, Text Type: N, H10
[49984278]
A customer in the united states notified biomerieux of discrepant results associated with nuclisens easymag magnetic silica 384t (reference 280133) lot - z017bb1ms. The customer reports low recovery with the nuclisens easymag magnetic silica; their downstream assays are a pcr, ebv and bkv.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00119 |
| MDR Report Key | 5808631 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-20 |
| Date of Report | 2016-04-04 |
| Date Mfgr Received | 2016-04-04 |
| Date Added to Maude | 2016-07-20 |
| 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 |
| Reporter Occupation | HOME HEALTH AIDE |
| 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 | BIOMERIEUX, SA |
| Manufacturer Street | CENTRE CHRISTOPHE M 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01 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 384T |
| Generic Name | NUCLISENS? EASYMAG? MAGNETIC SILICA 384T |
| Product Code | LDT |
| Date Received | 2016-07-20 |
| Catalog Number | 280133 |
| Lot Number | Z017BF1MS |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-20 |