FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3102968
·
Received May 9, 2013
Report
- Report Number
- 1823260-2013-02847
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 13, 2013
- Report Date
- May 14, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER TESTED 5.5 INR ON THE COAGUCHEK XS SYSTEM. HE NOTICED BLOOD IN HIS STOOL AND WENT TO THE HOSPITAL. A SCOPE WAS INSERTED IN HIS THROAT AND ESOPHAGEAL BLEEDING WAS FOUND. A COMPARISON LAB RETURNED AS 4.1 INR. CALLER WAS TREATED WITH VITAMIN K AND 3 UNITS OF PLASMA. 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 |
|---|---|---|---|---|---|---|---|
| 203046 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21637421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 058 YR | VICODIN| ZOLOFT| ARTIFICIAL "HEART" VALVE| WARFARIN| CLONIDINE| PROTONIX| TOPROL XL |