FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK S SYSTEM
MDR report key: 1770977
·
Received November 13, 2007
Report
- Report Number
- 1823260-2007-09872
- Event Type
- Malfunction
- Date Received
- November 13, 2007
- Date of Event
- November 5, 2007
- Report Date
- November 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JPA
- PMA / PMN Number
- K974569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK S SYSTEM. (B) (4)
Description of Event or Problem · 1
PATIENT REPORTEDLY TESTED 2.9 INR ON HIS COAGUCHEK XS SYSTEM AND 3.9 INR ON THE COAGUCHEK S AT HIS PHYSICIAN'S OFFICE. DOCTOR DID NOT CHANGE HIS COUMADIN DOSE BASED ON THE COAGUCHECK S VALUE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN. REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK S SYSTEM | PROTHROMBIN TIME TEST STIRPS - JPA | JPA | ROCHE DIAGNOSTICS | 616A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ASPIRIN 81 MG DAY| DIOVAN HCT 160/125 MG DAY| COUMADIN 7.5 MG DAY| CRESTOR 5 MG DAY| "RHOXALDIHIAZEM" 240 MG DAY |