FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK S SYSTEM
MDR report key: 1122806
·
Received August 14, 2008
Report
- Report Number
- 1823260-2008-06202
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 14, 2008
- Manufacturer
- ROCHE DIAGNOTICS
- Product Code
- JPA
- PMA / PMN Number
- K974569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CALLER STATES THE PT TESTED >8.0 INR ON THE COAGUCHEK S SYSTEM AND 2.3 INR ON A COMPARISON LAB. MEDICATION REMAINED UNCHANGED BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER NO STRIPS ARE AVAILABLE FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK S SYSTEM | PROTHROMBIN TEST STRIRPS - JPA | JPA | ROCHE DIAGNOTICS | 683A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | COZAAR| PLAVIX- 75MG/DAY| MULTIVITAMIN| "CULTRASIN"| METOPROLOL-75MG/DAY| FOLIC ACID| ALLOPURINOL-200MG/DAY| DIGOXIN| LIPITOR- 10MG/DAY |