FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2192681
·
Received August 5, 2011
Report
- Report Number
- 1823260-2011-04213
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- June 21, 2011
- Report Date
- February 13, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK XS SYSTEM (LOT NUMBER 20203611, EXPIRATION DATE 05/31/2012). (B)(4).
Description of Event or Problem · 1
CALLER REPORTS THAT DURING A (B)(6) STUDY THE FOLLOWING COAGUCHEK XS/S RESULTS WERE OBTAINED: 2.3 INR/1.8 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 | 20203611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 037 YR | WARFARIN |