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 2016-09-23 for NUCLISENS? EASYMAG? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[55467160]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55467162]
A customer in the united states contacted biom? Rieux to report downstream performance issues associated with the nuclisens? Easymag? Magnetic silica product. The customer performs luminex gpp - gastrointestinal panel, multiplex pcr. They use an internal control; it is rna virus. The acceptance criteria is positive (qualitative). The issue observed is an incorrect internal control result. The customer indicates a delay in reporting of up to 72 hours due to the need to re-process samples. The customer stated no patient results were affected because those that worked were reported and those where the internal control did not work were not reported. No patients were harmed or treated incorrectly. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[61004472]
This report was initially submitted following notification that a customer in the united states reported performance issues in association with nuclisens magnetic silica product. Biom? Rieux investigation was conducted. The investigation concluded the downstream performance issue observed by the customer is not due to the nuclisens magnetic silica product. Changes in pre-treatment components (lysis buffer) and sample volume used at the customer site resolved the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00345 |
| MDR Report Key | 5973097 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-23 |
| Date of Report | 2016-08-24 |
| Date Mfgr Received | 2016-08-24 |
| Device Manufacturer Date | 2015-12-16 |
| Date Added to Maude | 2016-09-23 |
| 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 | 2016-09-23 |
| Catalog Number | 280133 |
| Lot Number | Z017BC1MS |
| 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 | 2016-09-23 |