MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-08 for INRATIO * manufactured by Hemosense, Inc..
[539546]
Caller alleged discrepant results compared with the lab. Results as follows: date 2006, inratio 2. 1(thu) 1. 5, lab 8. 0(fri) 1. 9 patient was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
[7834651]
Discrepant results (accuracy) comparison of inratio test with lab results provided by end user at time complaint was filed: date 2006, inratio 2. 10thu) 1. 5, lab 8. 0 (fri) 1. 9, mean 5. 05 1. 7, confidence limits cannot be determined 1. 2-2. 3. Per internal procedure, tr, the mean of the inratio meter and comparative system inr were calculated. For the first set of data, the confidence limits cannot be determined. The time interval between two inratio and lab test was >3hours. Per tr, the comparison considered invalid. For the second set of data, both inratio and lab values are within the confidence limits for inr testing. Per tr, the results are not considered discrepant within the context of the documented variability for inr testing. This is an adverse event case. Product will be tested when returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954730-2006-00491 |
| MDR Report Key | 759522 |
| Date Received | 2006-09-08 |
| Date of Report | 2006-09-06 |
| Date of Event | 2006-09-06 |
| Date Mfgr Received | 2006-09-06 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-09-14 |
| 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 | 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 | PROTHROMIN TIME TEST |
| Product Code | GIS |
| Date Received | 2006-09-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 060218 |
| ID Number | * |
| Device Expiration Date | 2007-07-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 747443 |
| Manufacturer | HEMOSENSE, INC. |
| Manufacturer Address | * SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-08 |