MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-15 for URISYS 2400 U2400 03051323001 manufactured by Roche Diagnostics.
[17061339]
User experienced two pt samples which generated results for erythrocytes from the analyzer that did not compare with results from the microscopic examination. The following pt sample was determined to be discrepant. Initial erythrocyte result from analyzer was negative. Microscopic examination of the same urine sample showed 5 to 10 rbcs per hpf. Sample was repeated on the analyzer generating a negative result for erythrocytes. Both dipstick and microscopic results were reported for this pt sample. User states the pt would not have been treated for the negative result that was reported on the dipstick. The user did not have info as to whether the pt was adversely affected by not receiving treatment.
Patient Sequence No: 1, Text Type: D, B5
[17315905]
Although the field service representative was unable to verify the problem, he noted a problem with the calibration as a cause. He verified default settings for reflectance, performed a calibration and ran controls to verify analyzer performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2009-02731 |
| MDR Report Key | 1437735 |
| Report Source | 05,06 |
| Date Received | 2009-04-15 |
| Date of Report | 2009-04-15 |
| Date of Event | 2009-03-20 |
| Date Facility Aware | 2009-03-25 |
| Report Date | 2009-03-25 |
| Date Mfgr Received | 2009-03-25 |
| Date Added to Maude | 2009-09-08 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | HITACHI HIGH TECH CORP |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URISYS 2400 |
| Generic Name | AUTOMATED URINE ANALYZER - JIL |
| Product Code | JIO |
| Date Received | 2009-04-15 |
| Model Number | U2400 |
| Catalog Number | 03051323001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-15 |