FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3111662
·
Received May 14, 2013
Report
- Report Number
- 1823260-2013-02919
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 16, 2013
- Report Date
- June 5, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 5.4 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.7 INR. PATIENT'S COUMADIN WAS HELD FOR ONE DAY BASED ON THE LAB 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 |
|---|---|---|---|---|---|---|---|
| 213338 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21611311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 064 YR | COUMADIN| UNK LANCET DEVICE| UNK BLOOD SUGAR METER |