FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 4171621
·
Received October 14, 2014
Report
- Report Number
- 1823260-2014-07882
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 11, 2014
- Report Date
- October 14, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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
REPORTER STATED PATIENT TESTED 5.1 INR ON THE COAGUCHEK XS PLUS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.9 INR. PATIENT'S COUMADIN DOSAGE WAS REDUCED BASED ON THE METER RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, THE VIAL HAS BEEN USED UP AND DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650363 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22074511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 049 YR | LIPITOR| COUMADIN| MULTIVITAMIN| ACETAMINOPHEN/BUTALBITAL/CAFF| PREDNISONE| TIZANIDINE |