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 2018-05-02 for EMAG? 418591 manufactured by Biomerieux Italia S.p.a..
[107826009]
A customer from (b)(6) notified biom? Rieux of crystallization on the distribution nozzles of the emag? Instrument (ref 418591). The customer reported that there were blood crystals on this nozzle resulting in potential specimen contamination. There is no indication from the laboratory that the described issue led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00064 |
| MDR Report Key | 7480029 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-02 |
| Date of Report | 2018-10-16 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-05-02 |
| 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 | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX ITALIA S.P.A. |
| 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? |
| Generic Name | EMAG? |
| Product Code | JJH |
| Date Received | 2018-05-02 |
| Model Number | 418591 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX ITALIA S.P.A. |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |