FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK® XS SYSTEM
MDR report key: 2800451
·
Received October 22, 2012
Report
- Report Number
- 1823260-2012-05296
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- September 20, 2012
- Report Date
- October 22, 2012
- 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). IT WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
THE COAGUCHEK XS SYSTEM WAS COMPARED WITH A LABORATORY. RESULTS OF 2.0 INR AND 3.1 INR WERE REPORTED. IT IS UNKNOWN WHICH COMPARATIVE SYSTEM YIELDED WHICH RESULT. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER TEST STRIPS HAVE BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAGUCHEK® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21333414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 054 YR | FALITHROM |