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 2018-03-07 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biomerieux Sa.
[102107797]
A customer in (b)(6) reported a leakage problem with the nuclisens? Easymag? Disposable (lot z109dn). The customer reported the first well of the vessel was cracked and the sample leaked into the easymag instrument. There is no indication from the laboratory that the issue led to discrepant results or adverse events related to the patient, nor any report that the leaking vessel led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00026 |
| MDR Report Key | 7320659 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-07 |
| Date of Report | 2018-08-16 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-03-07 |
| 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 | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, 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? DISPOSABLE |
| Generic Name | NUCLISENS? EASYMAG? DISPOSABLE |
| Product Code | JJH |
| Date Received | 2018-03-07 |
| Catalog Number | 280135 |
| Lot Number | Z109DN |
| Device Expiration Date | 2019-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES GRENOBLE CEDEX 01, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |