FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK® XS SYSTEM
MDR report key: 1910066
·
Received November 30, 2010
Report
- Report Number
- 1823260-2010-07052
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- April 26, 2010
- Report Date
- December 17, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
CALLER STATES THE PATIENT TESTED 3.4 INR ON THE COAGUCHEK XS SYSTEM AND 2.6 INR ON THE COMPARISON LAB. CALLER STATES THAT THE PATIENT WAS TREATED WITH TWO 10 MG TABLETS OF WARFARIN BASED ON THE METER RESULTS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS PAIN AND STIFFNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | 20181931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 057 YR | WARFARIN |