FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK® XS SYSTEM
MDR report key: 3180173
·
Received June 20, 2013
Report
- Report Number
- 1823260-2013-03748
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 13, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CALLER TESTED 2.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.8 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER CALLER WILL NOT BE RETURNING THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280166 | COAGUCHEK® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR | "ZIWAZER"| "ANTODIPIN"| MARCUMAR |