FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3955279
·
Received July 24, 2014
Report
- Report Number
- 1823260-2014-05499
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Date of Event
- June 27, 2014
- Report Date
- August 26, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 3.5 INR AND 2.1 INR ON THE COAGUCHEK XS SYSTEM. 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 |
|---|---|---|---|---|---|---|---|
| 433799 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22370722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 078 YR | FINASTERIDE| FISH OIL| CHLORTHALIDONE| WARFARIN| ASPIRIN| STENT| AMLODIPINE| IRBESARTAN| MULTI-VITAMIN| METOPROLOL| ATORVASTATIN |