MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-05-03 for INRATIO * manufactured by Hemosense, Inc..
[21251525]
Caller alleged discrepant results when compared with the lab/point of care device. Results reported as folllows:date inratio pocd inr/lab mean confidence limits4/11/06 3. 8 3. 4 3. 75 2. 2-5. 3 4. 0 3. 4 3. 7 2. 2-5. 3 3. 8 2. 5 3. 15 1. 9-4. 6 4. 0 2. 5 3. 25 1. 9-4. 6
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954730-2006-00244 |
| MDR Report Key | 710008 |
| Report Source | 04 |
| Date Received | 2006-05-03 |
| Date of Report | 2006-04-27 |
| Date of Event | 2006-04-12 |
| Date Mfgr Received | 2006-04-12 |
| Date Added to Maude | 2006-05-11 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 651 RIVER OAKS PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4082403800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INRATIO |
| Generic Name | PROTHROMBIN TIME TEST |
| Product Code | GIS |
| Date Received | 2006-05-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | NI |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 699050 |
| Manufacturer | HEMOSENSE, INC. |
| Manufacturer Address | * SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-03 |