MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-14 for URISYS 1100 03617556690 manufactured by Roche Diagnostics.
[1959921]
The user received questionable results for one patient urine sample that were abnormal then repeated as normal. Of the data provided, the results for the following assays were discrepant. The initial leukocyte result was 500 leu/ul and the repeat result was negative. The initial protein result was 500 mg/dl and the repeat result was negative. The initial glucose result was 250 mg/dl and the repeat result was normal. The user was not sure which results were correct and did not have any information about the patient's condition or whether patient was affected by erroneous results. No adverse events were alleged regarding the event. The lot number of the chemstrip 10 md urine test strips was 23063844.
Patient Sequence No: 1, Text Type: D, B5
[9097122]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[16938052]
A specific root cause could not be determined. No materials were returned for investigation. Retention material was tested and was found within specification.
Patient Sequence No: 1, Text Type: N, H10
[21870421]
No product has been returned and therefore no evaluation has occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-01359 |
| MDR Report Key | 2016920 |
| Report Source | 05,06 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-02-22 |
| Date Mfgr Received | 2011-02-22 |
| Date Added to Maude | 2011-03-14 |
| 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 RICHEAL CLINE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213833 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| 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 | 2011-03-14 |
| Model Number | NA |
| Catalog Number | 03617556690 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-03-14 |