MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-02 for VIDAS ANALYZER 99735 manufactured by Biom?rieux Italia.
[25503650]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[25503651]
A customer in the united states reported qcv failure on slot in association with the vidas? Analyzer ((b)(4)). The customer repeated the qcv test; the same failure occurred. The last successful qcv was performed (b)(6) 2015. The local field service engineer (fse) performed a site evaluation on (b)(6) 2015 and reported a seal required cleaning. Following fse actions, a subsequent qcv run was performed and passing results indicated the system is performing to specifications. There was no reported death or serious injury associated with the identified event. Internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[36737890]
Biom? Rieux investigation was performed at the customer site by the local field service engineer (fse). The qcv failure was reproduced in section by the fse. Investigation identified debris in section. The fse removed the debris and performed qualification tests. Following repair, the qcv test passes; the section is performing in accordance with specifications. The vidas? System was returned to operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00079 |
| MDR Report Key | 5051495 |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-21 |
| Date Mfgr Received | 2015-08-21 |
| Date Added to Maude | 2015-09-02 |
| 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, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS ANALYZER |
| Generic Name | VIDAS ANALYZER |
| Product Code | DEW |
| Date Received | 2015-09-02 |
| Model Number | 99735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |