MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-10 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.
[30873923]
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
[30873924]
Reporter stated that back-to-back testing was performed on the urisys 1100 which, for test 1, yielded a protein result of 100 mg/dl and a glucose result of 250 mg/dl, while test 2 showed values of negative for protein and normal for glucose. No adverse event was reported. The manufacturer requested the return of the suspect product for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[35048328]
No investigation was done on the suspect device as the urisys 1100 device was not returned. The customer did return the chemstrip 10 md urine test strips. All results using the returned strips were in accordance to the testing plan. There were no false negative results at the urisys 1100 device observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04501 |
| MDR Report Key | 5213872 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-10 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-10-06 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-11-10 |
| 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 | 2015-11-10 |
| Model Number | NA |
| Catalog Number | 03617556001 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| 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 | 2015-11-10 |