FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2222079
·
Received August 24, 2011
Report
- Report Number
- 1823260-2011-04544
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 26, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.6 INR. NO ACTIONS TAKEN BASED ON METER 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 ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 20332211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 081 YR | "THYREVIN" DAILY| COUMADIN DAILY| LASIX ONCE DAILY| ARMOUR THYROID ONCE DAILY| "RESTOW" AT NIGHT| SULFASALAZINE TWICE DAILY| SOTALOL ONCE DAILY| B12 DAILY| COREG TWICE DAILY| LISINOPRIL TWICE DAILY| BABY ASPIRIN ONCE DAILY |