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 2017-02-20 for NUCLISENS? EASY MAG? DISPOSABLE VESSEL 280135 manufactured by Biom?rieux Sa.
[67944032]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[67944033]
A customer in the united states reported the occurrence of various liquid level sense (lls) errors (e4713, e4714, e4717) in association with the nuclisens? Easymag?. The customer stated that patient results were impacted in that there was a delay in reporting. Product stop shipment (b)(4) was issued 19jan2017 due to an identified performance issue with this product/lot which may lead to a delay of results. An internal biom? Rieux investigation has been conducted. The investigation reproduced the reported issue with the referenced batch (z107nb); this batch is included in the (b)(4). There is no indication or report from the laboratory that the reported issue led to any adverse event related to any patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00023 |
| MDR Report Key | 6343170 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-01-27 |
| Date Mfgr Received | 2017-01-27 |
| Device Manufacturer Date | 2007-02-16 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? EASY MAG? DISPOSABLE VESSEL |
| Generic Name | NUCLISENS? EASY MAG? DISPOSABLE VESSEL |
| Product Code | JJH |
| Date Received | 2017-02-20 |
| Catalog Number | 280135 |
| Lot Number | Z107NB |
| 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 GRENOBLE CEDEX 01, FR 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-20 |