FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK XS SYSTEM
MDR report key: 1003461
·
Received February 21, 2008
Report
- Report Number
- 1823260-2008-01758
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 21, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CALLER STATES THE PT TESTED APPROXIMATELY 4.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS APPROXIMATELY 1.0 INR. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK XS SYSTEM | PROTHROMBIN TIME TEST STRIPS - GJS | GJS | ROCHE DIAGNOSTICS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |