MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-25 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.
[5508067]
Reporter stated that a patient sample was tested on the urisys 1100 which returned a negative result for leukocytes. Within 4 hours, the same sample was reportedly tested on a laboratory instrument which reported a value of ++ for leukocytes (approximately 300 wbc/hpf). No adverse event was reported. The manufacturer requested the return of the suspect product for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[12847704]
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 | 1823260-2015-01542 |
| MDR Report Key | 4544960 |
| Report Source | 06 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-01-29 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2015-02-25 |
| 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 MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | 2015-02-25 |
| Returned To Mfg | 2015-03-05 |
| Model Number | NA |
| Catalog Number | 03617556001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| 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 | 2015-02-25 |