MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for NUCLISENS? EASYMAG? MAGNETIC SILICA 384T 280133 manufactured by Biom?rieux Sa.
[72805301]
An internal investigation concluded: no significant difference was observed between the impacted silica batches and the reference lots. During internal testing, the event was reproduced with tubes exposed at freezing temperature (-19/-31? C) for the silica. The ratio of silica particles is really low with a long period of freezing. No issue was observed in regards to the amount of silica. The nucl. Magn. Silica 384t (reference (b)(4)) 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
[72805302]
A customer in (b)(6) notified biom? Rieux that some batches of product have less silica than others. The customer reported that after the extraction they can see less silica than what is normally observed and that they missed some peak positives. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00072 |
| MDR Report Key | 6486531 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-04-12 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES BERGES CEDEX 01 |
| Manufacturer City | GRENOBLE, 38024 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUCLISENS? EASYMAG? MAGNETIC SILICA 384T |
| Generic Name | NUCLISENS? EASYMAG? MAGNETIC SILICA 384T, LDT |
| Product Code | LDT |
| Date Received | 2017-04-12 |
| Catalog Number | 280133 |
| Lot Number | Z018BD1MS |
| Device Expiration Date | 2018-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES CEDEX 01 GRENOBLE, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |