MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-26 for URISYS 1100 U1100 03617556690 manufactured by Roche Diagnostics.
[785393]
One pt urine sample with discrepant results for blood, compared to repeat results from another analyzer - same methodology. Initial result gave 50 ul; repeat resulted negative. Microscopic exam of same sample showed negative for blood. No adverse events reported in association with the results. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2008-01842 |
| MDR Report Key | 1006898 |
| Report Source | 05,06 |
| Date Received | 2008-02-26 |
| Date of Report | 2008-02-26 |
| Date of Event | 2008-01-31 |
| Date Facility Aware | 2008-01-31 |
| Report Date | 2008-01-31 |
| Date Mfgr Received | 2008-01-31 |
| Date Added to Maude | 2008-05-07 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG |
| Manufacturer Street | TEGIMENTA FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URISYS 1100 |
| Generic Name | AUTOMATED URINE ANALYZER |
| Product Code | JIO |
| Date Received | 2008-02-26 |
| Model Number | U1100 |
| Catalog Number | 03617556690 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005176 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-26 |