FDA Adverse Event
Injury
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3981305
·
Received August 5, 2014
Report
- Report Number
- 1823260-2014-05888
- Event Type
- Injury
- Date Received
- August 5, 2014
- Date of Event
- June 25, 2014
- Report Date
- August 27, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 4.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.6 INR. AN ULTRASOUND WAS DONE ON THE CALLER'S LEG, AND A BLOOD CLOT WAS DISCOVERED. THE CALLER WAS TREATED WITH A TISSUE PLASMINOGEN ACTIVATOR (TPA), AND HAD SURGERY 2 DAYS LATER. THE CALLER WAS RELEASED FROM THE HOSPITAL FOUR DAYS LATER. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457927 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22118521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 050 YR | Required Intervention | WARFARIN| UNK BLOOD SUGAR METER |