FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3790022
·
Received May 5, 2014
Report
- Report Number
- 1823260-2014-03172
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- April 7, 2014
- Report Date
- June 23, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 TESTED >8.0 INR INR ON THE COAGUCHEK XS PLUS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.8 INR. NO TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268977 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22290611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 069 YR | NIACIN| CLONIDINE| DRONEDARONE| ASPIRIN| MULTIVITAMIN| CRESTOR| COUMADIN| INTEGRA| TRIBENZOR| METOPROLOL TARTRATE |