MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-03 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.
[30281636]
It is not known if the initial reporter has or intends to report the event to fda.
Patient Sequence No: 1, Text Type: N, H10
[30281637]
Reporter stated that the urisys 1100 produced negative results for leukocytes and erythrocytes, while a visual read of the test strip showed values of 500 leukocytes/microliter and 250 erythrocytes/microliter respectively. No adverse event was reported. The manufacturer requested the return of the suspect product for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[35019289]
The urisys device with the serial number (b)(4) was received. There were no noticeable defects to be seen. The retention material of lot 233 488 00 was tested on the customer device and an investigation unit urisys 1100 device. There were no false negative results observed. The measurements on the customer device and the investigation unit device are comparable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04438 |
| MDR Report Key | 5198408 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-03 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-10-08 |
| Date Mfgr Received | 2015-10-09 |
| Date Added to Maude | 2015-11-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| 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 | 2015-11-03 |
| Returned To Mfg | 2015-11-11 |
| Model Number | NA |
| Catalog Number | 03617556001 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| 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 | 2015-11-03 |