MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for ELECSYS AFP ASSAY manufactured by Roche Diagnostics.
[133503267]
The investigations found the issue was caused by the afp reagent pack. The follow up/corrective actions were the replacement of the reagent pack. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[133503268]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90000 |
| MDR Report Key | 8256689 |
| Date Received | 2019-01-17 |
| Date Added to Maude | 2019-01-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECSYS AFP ASSAY |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2019-01-17 |
| Model Number | AFP |
| Lot Number | 31718 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |