FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2111649
·
Received June 2, 2011
Report
- Report Number
- 1823260-2011-02946
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 20, 2011
- Report Date
- August 11, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 STATES HE TESTED 4.0 INR ON THE COAGUCHEK XS SYSTEM AND 3.0 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 20306222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 066 YR | COUMADIN| PACEMAKER| OMEGA 3 FISH OIL| FIBER| "TAMAZAPINE"| TRICOR| LANOXIN| POTASSIUM CHLORIDE| TOPROL| REMERON| WELLBUTRIN| LASIX| VYTORIN| INSPRA |