MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-03 for URISYS 1100 03617556690 manufactured by Roche Diagnostics.
[9103160]
The urisys 1100 meter was returned for investigation. The meter as well as a urisys 1100 from the investigational unit were checked with 0- artificial urine, 0-native urine, and a leukocyte dilution series. All results were within the specified ranges. It was determined the returned meter performed within specification and no malfunction was observed. As the user did not return the affected test strips nor provide the lot number, further investigation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[16258423]
The user received a questionable leukocyte result for one patient sample. The instrument read the strip as negative and the leukocyte result by visual reading was 100 (no unit of measure was provided). A microscopic analysis was done and confirmed the positive visual reading at 14-15 white blood cells. No adverse events were alleged. The lot number of the chemstrip 10 md urine test strips was not provided.
Patient Sequence No: 1, Text Type: D, B5
[16334754]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00553 |
| MDR Report Key | 1977673 |
| Report Source | 05,06 |
| Date Received | 2011-02-03 |
| Date of Report | 2011-05-05 |
| Date of Event | 2010-11-08 |
| Date Mfgr Received | 2011-01-18 |
| Date Added to Maude | 2011-02-03 |
| 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 | NA RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URISYS 1100 |
| Generic Name | AUTOMATED URINE ANALYZER |
| Product Code | KHE |
| Date Received | 2011-02-03 |
| Model Number | NA |
| Catalog Number | 03617556690 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-02-03 |