MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-26 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.
[1301977]
The user received a negative result for leukocytes with the microscopic result of > 100 wbcs/hpf. The user retested with a new vial of strips, same lot number, and got a result of 2+ for leukocytes. The user tried a third vial and received a negative result for leukocytes. The patient was not treated or adversely affected due to the erroneous results. The reagent strip lot number was 23052942.
Patient Sequence No: 1, Text Type: D, B5
[1343943]
Per the clinic, the patient experienced recurring infections at the implant site. The device was explanted (b)(6) 2010, and there are no plans to reimplant as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
[1401057]
Caller reports lancet protrudes beyond the end cap of the multiclix device after firing. No accidental needle stick occurred. No adverse event reported. Requested return of suspect device and replacement was sent.
Patient Sequence No: 1, Text Type: D, B5
[8545210]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[8548420]
It was unknown if the initial reporter sent report to the fda. Correction being sent. Device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02469 |
| MDR Report Key | 1667015 |
| Report Source | 05,06 |
| Date Received | 2010-04-26 |
| Date of Report | 2011-02-04 |
| Date of Event | 2010-04-08 |
| Date Mfgr Received | 2010-04-08 |
| Date Added to Maude | 2010-07-08 |
| 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 | 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 | 2010-04-26 |
| Returned To Mfg | 2010-07-08 |
| Model Number | NA |
| Catalog Number | 03617556001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2010-04-26 |