MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-13 for URISYS 1100 03617556690 manufactured by Roche Diagnostics.
[1676481]
The user received questionable nitrite, blood and leukocyte results for one urine sample tested on the urisys 1100 analyzer. Of the data provided, the blood results were discrepant. The initial result from the analyzer was negative. When the urine chemstrip was tested manually, the blood result was 1+ (one plus). No adverse events were alleged regarding the event.
Patient Sequence No: 1, Text Type: D, B5
[8799809]
.
Patient Sequence No: 1, Text Type: N, H10
[9122527]
The urine analyzer and strips were returned for investigation. The returned materials and retention materials were investigated. It was determined there was no indication of a product malfunction which caused or contributed to the event reported by the customer. No adverse events were alleged regarding the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07373 |
| MDR Report Key | 1920626 |
| Report Source | 05,06 |
| Date Received | 2010-12-13 |
| Date of Report | 2011-05-13 |
| Date of Event | 2010-12-01 |
| Date Mfgr Received | 2010-12-01 |
| Date Added to Maude | 2011-04-07 |
| 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 | 3 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| 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 | 2010-12-13 |
| Model Number | NA |
| Catalog Number | 03617556690 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL ASSISTANT |
| 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 | 2010-12-13 |