MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for TEST, TIME, PROTHROMBIN manufactured by Coagusense, Inc.
[184481448]
The patient had an international normalized ratio (inr) done in the office. His inr was 2. 1. His coumadin is managed by the coumadin clinic and when he reported it to them, he was told that it did not seem right. So, he was told to go to a lab to have it repeated. He went to the lab and had the inr repeated and it was 3. 2. Call received from coumadin clinic the following day to report the discrepancy of the patients inr readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9864932 |
| MDR Report Key | 9864932 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-10 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TEST, TIME, PROTHROMBIN |
| Product Code | GJS |
| Date Received | 2020-03-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COAGUSENSE, INC |
| Manufacturer Address | 48377 FREMONT BLVD STE 113 FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |