FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2379604
·
Received December 16, 2011
Report
- Report Number
- 1823260-2011-06767
- Event Type
- Malfunction
- Date Received
- December 16, 2011
- Date of Event
- December 2, 2011
- Report Date
- January 31, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 5.05 INR. PATIENT'S COUMADIN DOSE WAS HELD BASED ON THE LAB VALUE AND SHE RECEIVED ORAL VITAMIN K. 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 | ROCHE DIAGNOSTICS | NA | 20530711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 087 YR | ISOSORBIDE MONONITRATE| METOPROLOL| COUMADIN| LEVOTHYROXINE| TYLENOL| TYLENOL PM| SIMVASTATIN| RANEXA| EFFEXOR| HCTZ/TRIAMTERENE| DIGOXIN |