MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-21 for URISYS 1100 U1100 03617556690 manufactured by Roche Diagnostics.
| Report Number | 1823260-2010-00435 |
| MDR Report Key | 1587952 |
| Report Source | 05,06 |
| Date Received | 2010-01-21 |
| Date of Report | 2011-02-04 |
| Date of Event | 2010-01-04 |
| Date Facility Aware | 2010-01-04 |
| Report Date | 2010-01-04 |
| Date Mfgr Received | 2010-01-04 |
| Date Added to Maude | 2010-11-12 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URISYS 1100 |
| Generic Name | AUTOMATED URINE ANALYZER - KHE |
| Product Code | KHE |
| Date Received | 2010-01-21 |
| Model Number | U1100 |
| Catalog Number | 03617556690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |