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 2017-10-23 for NUCLISENS? EASY MAG? DISPOSABLE VESSEL 280135 manufactured by Biomerieux Sa.
[90756435]
A customer in the united states notified biom? Rieux of a performance issue associated with nuclisens? Easy mag? Disposable vessel ((b)(4)). The customer reported that the tip was missing from the cartridge after run completion on two (2) different easymags (em 5 and em 9). On both occurrences, the issue was on cartridge position a the second tip position. After the runs completed, the second tip from the left on both affected tip cartridges were missing. The customer reported this lead to a delay in reporting results less than 24 hours, and there no indication or report that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00308 |
| MDR Report Key | 6969078 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-23 |
| Date of Report | 2018-02-14 |
| Date Mfgr Received | 2018-01-18 |
| Device Manufacturer Date | 2017-03-03 |
| Date Added to Maude | 2017-10-23 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| 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 | 3 |
| Brand Name | NUCLISENS? EASY MAG? DISPOSABLE VESSEL |
| Generic Name | NUCLISENS? EASY MAG? DISPOSABLE VESSEL |
| Product Code | JJH |
| Date Received | 2017-10-23 |
| Catalog Number | 280135 |
| Lot Number | Z108HB |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 CEDEX 01 GRENOBLE, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-23 |