MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-25 for COBAS 8100 manufactured by Roche Diagnostics International Ltd..
| Report Number | MW5088385 |
| MDR Report Key | 8830956 |
| Date Received | 2019-07-25 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-01-13 |
| Date Added to Maude | 2019-07-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 8100 |
| Generic Name | CALCULATOR / DATA PROCESSING MODULE |
| Product Code | JQP |
| Date Received | 2019-07-25 |
| Model Number | COBAS 8100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS INTERNATIONAL LTD. |
| Brand Name | COBAS 8000 |
| Generic Name | ANALYZER/CHEMISTRY PHOTOMETRIC DISCRETE |
| Product Code | JJE |
| Date Received | 2019-07-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS INTERNATIONAL LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-25 |