FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 4191747
·
Received October 22, 2014
Report
- Report Number
- 1823260-2014-08130
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 26, 2014
- Report Date
- October 22, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CALLER TESTED 6.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.8 INR. CUSTOMER DECREASED HIS COUMADIN DOSE BASED ON THE METER RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT STRIPS, HOWEVER, THE SUSPECT STRIPS HAVE BEEN DISCARDED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672318 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 075 YR | ARTIFICIAL KNEE| ARTIFICIAL KNEE| ASPIRIN| VITAMIN D| COUMADIN| METOPROLOL| DEFIBRILLATOR| MUCINEX| CALCIUM| VITAMIN B12| ARTIFICIAL HEART VALVE| DILTIAZEM |