FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3091981
·
Received May 3, 2013
Report
- Report Number
- 1823260-2013-02728
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 5, 2013
- Report Date
- June 12, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 6.0 INR ON THE COAGUCHEK XS SYSTEM; THE PATIENT WAS COUGHING UP BLOOD AND WAS ADVISED TO GO TO THE EMERGENCY ROOM (ER) BASED ON THE DEVICE RESULT. A COMPARISON LAB RETURNED AS 4.0 INR AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194594 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21637512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COUMADIN| LVAD| ASPIRIN |