MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-25 for URISYS 1100 U1100 03617556690 manufactured by Roche Diagnostics.
[785392]
One pt urine sample that resulted negative for blood. Visual dipstick of same showed 2+ or 3+ for blood. Urine sample repeated an add'l time giving the same results. If add'l info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2008-01843 |
| MDR Report Key | 1006896 |
| Report Source | 05,06 |
| Date Received | 2008-02-25 |
| Date of Report | 2008-02-26 |
| Date of Event | 2008-01-30 |
| 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 |
| 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 | 2008-02-25 |
| Model Number | U1100 |
| Catalog Number | 03617556690 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005188 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-25 |