FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK S SYSTEM
MDR report key: 1140605
·
Received August 28, 2008
Report
- Report Number
- 1823260-2008-06498
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JPA
- PMA / PMN Number
- K974569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 1. REFERENCE MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK S SYSTEM 2.
Description of Event or Problem · 1
CALLER STATES THE PATIENT TESTED 5.1 INR AND 2.8 INR ON COAGUCHEK S SYSTEM 1 WHILE COAGUCHEK SYSTEM 2 PRODUCED A RESULT OF 2.2 INR DURING DUPLICATE TESTING. NO ACTION TAKEN ON DEVICE 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 S SYSTEM | PROTHROMBIN TIME TEST STRIPS- JPA | JPA | ROCHE DIAGNOSTICS | 726A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | VERAPAMIL: 240MG/DAY| LIPITOR: 10MG/DAY| WARFARIN: 6MG/1DAY| DIGOXIN: 0.25MG/DAY |