FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2922752
·
Received January 18, 2013
Report
- Report Number
- 1823260-2013-00342
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- December 14, 2012
- Report Date
- January 23, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 5.5 INR AND 7.5 INR ON THE COAGUCHEK XS SYSTEM. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28090 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21625121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 061 YR | TRAZODONE ONCE DAILY| ALBUTEROL INHALER| FLONASE| WARFARIN| MECHANICAL MITRAL VALVE| MECHANICAL AORTIC VALVE| CRESTOR| POTASSIUM CHLORIDE DAILY| ASPIRIN| WELLBUTRIN ONCE DAILY| CHLORAZEPAM DAILY| FUROSEMIDE| ADVAIR EVERY 12 HOURS| FENOFIBRATE| TRAMADOL 3/DAY| "HYDROCODONE" |