FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK® XS SYSTEM
MDR report key: 2830601
·
Received November 13, 2012
Report
- Report Number
- 1823260-2012-05736
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- October 18, 2012
- Report Date
- December 11, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER TESTED 1.8 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.6 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 | 21333412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 074 YR | RAMIPRIL| LANSOPRAZOLE| DOXAZOSIN| "NEBELETT"| WARFARIN |