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 2018-08-10 for EMAG? SYSTEM 4704256 manufactured by Biomerieux Sa.
[116718349]
A customer in (b)(6) notified biom? Rieux of potential contamination associated with emag? System (reference 470456). The customer reported that there was a potential contamination on a sample adjacent to an uls error sample on the emag system. Sample results on (b)(6) 2018 for batch z109gpbnm at 9:32 am left section: - vessel position 1. 2 skin swab id = (b)(6) / error 1076 ultrasonic reading below threshold => not extracted. - vessel position 1. 3 csf id = (b)(6) pcr amplification result altona: (b)(6). A second run extraction on the same two samples performed on (b)(6) 2018 at 15:38 vessel 1 position 1 and 2 no uls error on the skin sample altona amplification: (b)(6). Id = (b)(6) csf negative. There was no impact to the patient due to this issue. However, there was a delay in reporting results greater than 24 hours. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00140 |
| MDR Report Key | 7771781 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-10 |
| Date of Report | 2018-11-05 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA |
| Manufacturer City | 50012 BAGNO A RIPOLI, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMAG? SYSTEM |
| Generic Name | EMAG? SYSTEM |
| Product Code | JJH |
| Date Received | 2018-08-10 |
| Model Number | 4704256 |
| 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 | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-10 |