FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK XS SYSTEM
MDR report key: 1243233
·
Received November 7, 2008
Report
- Report Number
- 1823260-2008-08240
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 28, 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
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CALLER STATES THE PATIENT TESTED 6.2 INR ON THE COAGUCHEK XS SYSTEM AND 4.71 INR ON A COMPARISON LAB. COUMADIN WAS HELD FOR TWO DAYS. 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 | 20164832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | BONIVA - 150 MG/MONTH| LANTUS - 200 UNITS/DAY| MIRALAX| NITROGLYCERIN - 0.4 MG/AS NEEDED| MONOPRIL - 20-40 MG/DAY| OXYCONTIN - 10 MG/AS NEEDED| WARFARIN - 2.5 MG/6DAYS| LIPITOR - 40 MG/DAY| OMEPRAZOLE - 40 MG/DAY| TOPROL XL - 100 MG/DAY| TRICOR - 145 MG/DAY| SYMLIN - 1.8 MG/DAY |