FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK XS SYSTEM
MDR report key: 1243236
·
Received November 7, 2008
Report
- Report Number
- 1823260-2008-08243
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 30, 2008
- Report Date
- November 7, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 1. REFERENCE MEDWATCH WITH FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 2.
Description of Event or Problem · 1
CALLER STATES THE PT TESTED 1.5 INR ON COAGUCHEK SYSTEM 1 AND 2.3 INR ON COAGUCHEK SYSTEM 2 DURING DUPLICATE TESTING. UNK ACTION TAKEN ON 2.3 INR RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK XS SYSTEM | PROTHROMBIN TIME TEST STRIPS- GJS | GJS | ROCHE DIAGNOSTICS | 20164031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | COUMADIN 4-5 YRS |