FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2263103
·
Received September 26, 2011
Report
- Report Number
- 1823260-2011-05066
- Event Type
- Malfunction
- Date Received
- September 26, 2011
- Date of Event
- September 12, 2011
- Report Date
- September 26, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
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 PATIENT TESTED 4.6 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.57 INR. PATIENT'S COUMADIN WAS INCREASED BASED ON THE LAB VALUE. 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 | 20303111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 036 YR | COUMADIN| MEDIPORT| ASPIRIN| MOTRIN| "SENA"| GRANISETRON| DEXAMETHASONE| OXALIPLATIN| 5-FLUOROURACIL| FILGRASTIM| PERCOCET| LEUCOVORIN| SARGRAMOSTIM| TYLENOL| PEGFILGRASTIM| HEPARIN |