FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2110362
·
Received June 1, 2011
Report
- Report Number
- 1823260-2011-02906
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 16, 2011
- Report Date
- August 2, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. OTHER: NA.
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED 2.9 INR, 2.7 INR, AND 1.9 INR ON THE COAGUCHEK XS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 20183231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 087 YR | PROTONIX DAILY| TYLENOL| LASIX| COUMADIN| CALCIUM PLUS D| VITAMIN B DAILY| WALKER| GEMFIBROZIL DAILY| ZOCOR DAILY| VITAMIN D HIGH-POTENCY| VITAMIN D DAILY| TRAMADOL| SENNOSIDES DAILY| METOPROLOL DAILY| TRAZODONE DAILY| NOVOLOG 70/30 AM/PM |