MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-01 for URISYS 1100 03617556690 manufactured by Roche Diagnostics.
[1400421]
The user complained of false negative results for one urine sample. The user could not provide specific test results, but stated all the results were negative. The sample was sent to another lab and the results were "positive for urinary tract infection as in bacteria, nitrite and leukocytes". No information was provided to determine if erroneous results were reported or if the patient was adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[1540764]
Adverse event(s): "no patient injury was reported" (no consequences or impact to patient). Product problem(s): "the system shut down" (loss of power). The nurse reported the system shut down during phaco. The system was rebooted and the case was completed as planned. The following case was also completed with no further problems noted. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8580326]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9018903]
The customer returned the urisys 1100 analyzer for investigation. The returned instrument was checked and all results were within the specified ranges. No malfunction was observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-03236 |
| MDR Report Key | 1702652 |
| Report Source | 05,06 |
| Date Received | 2010-06-01 |
| Date of Report | 2011-05-27 |
| Date of Event | 2010-05-21 |
| Date Mfgr Received | 2010-05-21 |
| Date Added to Maude | 2010-06-09 |
| 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 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 | 2010-06-01 |
| 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 | 2010-06-01 |