MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-09 for INRATIO * manufactured by Hemosense, Inc..
[569413]
Caller alleged imprecision with inratio. Results as follows: first test inr = 1. 7, second test inr = 1. 7; first test inr = 2. 3, second test inr = 2. 7; first test inr = 2. 4, second test inr = 2. 1, third test inr = 2. 1; first test inr = 2. 5, second test inr = 2. 4, third test inr = 2. 5.
Patient Sequence No: 1, Text Type: D, B5
[8055133]
Inratio precision data provided by end-user lot_ 060600: first test inr = 1. 7, second test inr = 1. 7, mean = 1. 0; sd = 0. 00; %cv = 0. 0%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further is required at this time. Inratio precision data provided by end-user lot 060600: first test inr = 2. 3, second test inr = 2. 7, mean = 2. 50; sd = 0. 28; %cv = 11. 3%. The time interval between inratio tests were done over 3 hours. Per tr0150, the comparison was invalid. No investigation required. Inratio precision data provided by end-user lot 060600: first test inr = 2. 4, second test inr = 2. 1, third test inr = 2. 1, mean = 2. 20; sd = 0. 17; %cv = 7. 9%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further testing is required at this time. Inratio precision data provided be end-user lot 060600: first test inr = 2. 5, second test inr = 2. 4, third test inr = 2. 5, mean = 2. 50; sd = 0. 06; %cv = 2. 3%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further testing is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954730-2007-00005 |
| MDR Report Key | 810120 |
| Date Received | 2007-01-09 |
| Date of Report | 2007-01-09 |
| Date of Event | 2006-12-21 |
| Date Mfgr Received | 2006-12-21 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-01-31 |
| 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 | 2007-01-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 060600 |
| ID Number | * |
| Device Expiration Date | 2008-01-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 797604 |
| Manufacturer | HEMOSENSE, INC. |
| Manufacturer Address | * SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-09 |