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 2017-02-20 for NUCLISENS? EASYMAG? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[67927237]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[67927238]
A customer in (b)(6) contacted biom? Rieux to report downstream performance issues associated with the nuclisens? Easymag? Magnetic silica product. The customer performs nested pcr and the method of detection is via agarose gel. They use an external control; positive controls are failing. The customer indicated that the reporting of patient results was delayed >24 hours; however, the customer also stated "to be fair, ours is a chronic disease management tool where a delay of a day is not "that" harmful. " the customer stated no patient results were affected because those that worked were reported and those where the external control did not work were not reported. No patients were harmed or treated incorrectly. Biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[75143133]
An internal biom? Rieux investigation was performed with results as follows: the nucl. Magn. Silica 384t (reference 280133) impacted batch z018ab1ms was tested on several downstream applications for rna (flu, (b)(6), enterovirus) and dna (bk). Low and high viral loads were tested. No significant difference was observed between the silica batch z018ab1ms and the reference. An issue (freezing) during shipment of silica could have occurred. Unfortunately, we were not able to visually inspect nor test the performances of the silica, as it was not returned to biom? Rieux. The shipping conditions of the nucl. Magn. Silica 384t_ ref 280133 from our manufacturing site to the subsidiary and then to the customer's laboratory were tested. The shipping conditions conform to our specifications, aimed at preventing any freezing of the magnetic silica. Nevertheless, as there is no temperature sensor in the nucl. Magn. Silica 384t_ ref 280133, we cannot totally exclude such an hypothesis. Neither could we exclude a freezing of the magnetic silica at the customer's laboratory. As an additional precaution, temperature sensors will be added in the nucl. Magn. Silica 384t_ ref 280133 shipping boxes to allow the detection of any potential freezing. In conclusion, biom? Rieux could not reproduce the customer's complaint. However, since we cannot totally exclude a freezing issue, we will implement some measures for detecting a freezing event. The nucl. Magn. Silica 384t (reference 280133) is highly sensitive to freezing and must be placed away from the walls of the refrigerators against which it is likely to freeze.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00033 |
| MDR Report Key | 6344360 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-20 |
| Date of Report | 2017-05-01 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2016-08-29 |
| Date Added to Maude | 2017-02-20 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? EASYMAG? MAGNETIC SILICA |
| Generic Name | NUCLISENS? EASYMAG? MAGNETIC SILICA |
| Product Code | LDT |
| Date Received | 2017-02-20 |
| Catalog Number | 280133 |
| Lot Number | Z018AB1MS |
| Device Expiration Date | 2018-01-28 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-20 |