FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 4191722
·
Received October 22, 2014
Report
- Report Number
- 1823260-2014-08127
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 22, 2014
- Report Date
- December 3, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 2.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.8 INR. CUSTOMER'S WARFARIN DOSE WAS INCREASED 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 |
|---|---|---|---|---|---|---|---|
| 673656 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22452921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 057 YR | LYRICA| HYDROCODONE| TORSEMIDE| MECHANICAL HEART VALVE| METANX| WARFARIN| NORTRIPTYLINE| BABY ASPIRIN| RAMIPRIL| CARVEDILOL| POTASSIUM CHLORIDE |