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 2016-09-09 for NUCLISENS? EASYMAG? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[54412397]
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 200ul 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
[54412398]
A customer in contacted biom? Rieux to report failure of the (b)(6) trial in association with the nuclisens? Easymag? Magnetic silica product. The customer repeated the trial using a different lot (z017na1ms) of silica; the test passed. Lot number z017ch1ms is included in the scope of field safety corrective action fsca-3037 (issued 08-jul-2016). The fsca contains an associated customer letter with guidance regarding testing with the magnetic silica. No abnormalities have been observed for patient results, and controls have been in range. No delay in reporting of patient results was identified. The customer states that all patient results reflect the patient's conditions. Pcr results for patients correlate to the nuclisens? Results. There is no indication or report from the laboratory or treating physician(s) that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the instand trial sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00163 |
| MDR Report Key | 5939052 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-12 |
| Date Mfgr Received | 2016-08-12 |
| Date Added to Maude | 2016-09-09 |
| 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 | 2016-09-09 |
| Catalog Number | 280133 |
| Lot Number | Z017CH1MS |
| Device Expiration Date | 2017-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-09 |