MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for EASYSTREAM (TM) 414352 manufactured by Biomerieux Sa.
[28571009]
Summary: customer reported the easystream (tm), sn (b)(4) is not providing an indication when eluates have not been distributed correctly (not alarming). Customer reports that there has been a delay of up to 48 hours no specific details have been provided. An investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[33469428]
Biom? Rieux internal investigation was conducted. The customer's issue was reproduced six (6) times in >3000 pipette attempts. Potential root causes, primary among them being excessive friction within the pipettor head, have been identified and analysis is being performed under corrective and preventive action (capa) record (b)(4). In the meantime, the following actions have occurred: easy stream instruments and pipettor heads in inventory at the international distribution center (idc) were returned to the supplier on (b)(4) 2015 for re-work, and subsequently received back for use on (b)(4) 2015. Product stop shipment (b)(4) was issued to subsidiaries and distributors 09 oct 2015. Biom? Rieux and the supplier defined a new quality control test for pipettor head performance verification. Field corrective action (b)(4) was issued to the field on 30 oct 2015 instructing replacement of the pipettor head at each customer site, using newly established quality control tests for performance confirmation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00113 |
| MDR Report Key | 5141314 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-07-29 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-10-09 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYSTREAM (TM) |
| Generic Name | EASYSTREAM (TM |
| Product Code | JQW |
| Date Received | 2015-10-09 |
| Catalog Number | 414352 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-09 |