MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-04 for URISYS 1100 03617556690 manufactured by Roche Diagnostics.
[15935644]
Reporter stated that a patient sample was tested on the urisys 1100 which reported a negative result for erythrocytes. A visual read of the test strip showed a result of 50 erythrocytes/microliter. Reporter stated that patient's urine sample was mixed and retested with results of 50 erythrocytes/microliter on both the urisys 1100 and a visual read of the test strip. No action based on the discrepant result was reported and no adverse event occurred. The manufacturer requested the return of the suspect product for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[15945981]
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
| Report Number | 1823260-2013-06748 |
| MDR Report Key | 3447194 |
| Report Source | 06 |
| Date Received | 2013-11-04 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2013-10-08 |
| Date Added to Maude | 2013-11-04 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | 2013-11-04 |
| Returned To Mfg | 2013-11-26 |
| Model Number | NA |
| Catalog Number | 03617556690 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-11-04 |