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 2018-03-22 for EMAG? 418591 manufactured by Biom?rieux Italia S.p.a..
[103692642]
A customer in france reported a contamination issue in association with the emag? Instrument. The customer reported that after the first sample run of the day, the sample drawer was removed, and there were drops of blood on the grid that is above the drawers. The blood was not dried or coagulated so it did not appear to be from the last run on the previous day. The technicians found additional blood when cleaning the underside of the grid. The pipettor was checked and there was no trace of blood around the pipetting head point. After assays, it appeared that the blood drops are due to the loading of the racks when the rack is clipped to the bottom of the drawer. An experiment was performed with tubes loaded with water and dye, and the same issue was observed. There is no indication from the laboratory that the issue led to discrepant results or adverse events related to a patient, nor any report that the blood exposure led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00046 |
| MDR Report Key | 7361610 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-22 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-03-10 |
| Date Added to Maude | 2018-03-22 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOM |
| 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 | 2018-03-22 |
| 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 | BIOM?RIEUX 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 | 2018-03-22 |