MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-04 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.
[2577847]
The user received questionable urinalysis results for one patient sample from the urisys 1100 analyzer, (b)(4). Of the data provided, the results for erythrocytes were discrepant. The initial result on the urisys 1100 analyzer was "negative" for erythrocytes. The strip visually showed about 50. A specimen was sent to the lab and reported back as trace for erythrocytes. The patient was not treated as the doctor wanted to wait on the lab results. The patient is a kidney patient with one kidney and the doctor expected to see some blood in the urine. No other information was provided about the patient. A request was made for the return of the affected product.
Patient Sequence No: 1, Text Type: D, B5
[9951359]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-01794 |
| MDR Report Key | 2517215 |
| Report Source | 06 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-03-08 |
| Date Added to Maude | 2012-04-04 |
| 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 |
| 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 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 | 2012-04-04 |
| Returned To Mfg | 2012-03-19 |
| Model Number | NA |
| Catalog Number | 03617556001 |
| 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 | 2012-04-04 |