FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 4171754
·
Received October 15, 2014
Report
- Report Number
- 1823260-2014-07906
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- July 30, 2014
- Report Date
- November 24, 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
- 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 3.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.8 INR. CUSTOMER'S COUMADIN DOSE WAS ADJUSTED 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 |
|---|---|---|---|---|---|---|---|
| 654712 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22370723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 053 YR | VITAMIN D| LANOXIN| SPIRONOLACTONE| METOPROLOL| COUMADIN| FOLIC ACID| PLAQUENIL| POTASSIUM| IRON| SYNTHROID| PROTONIX| DEMADEX| ISOSORBIDE| ASPIRIN| AMIODARONE| LIPITOR| PACEMAKER| LORATADINE| BONIVA| NITROGLYCERIN| CELLCEPT |