FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2042502
·
Received April 6, 2011
Report
- Report Number
- 1823260-2011-01916
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 15, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 7.1 INR AND 5.4 INR ON THE COAGUCHEK XS SYSTEM. CALLER'S WARFARIN DOSE WAS HELD FOR 2 DAYS. 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 | 20131223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 074 YR | METOPROLOL TWICE DAILY| ZOCOR| CALTRATE TWICE DAILY| LEVOTHYROXINE DAILY| OXYBUTYNIN DAILY| ATROVENT| FUROSEMIDE DAILY| "RAPINOLOL" DAILY| CENTRUM DAILY| "KOZAR" TWICE DAILY| WARFARIN DAILY| KLOR-CON 3 DAILY| CPAP MACHINE| COMBIVENT INHALER 2 DAILY| OSTEO BI-FLEX DAILY |