FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3163120
·
Received June 11, 2013
Report
- Report Number
- 1823260-2013-03541
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 16, 2013
- Report Date
- August 2, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
REPORTER STATED THAT A VENOUS SAMPLE OBTAINED FROM PATIENT WAS TESTED ON AN UNSPECIFIED LABORATORY INSTRUMENT WITH A RESULT OF 2.3 INR. ONE HOUR AND 32 MINUTES LATER, PATIENT TESTED ON THE COAGUCHEK XS SYSTEM WITH A RESULT OF 3.1 INR. NO ACTION BASED ON THE COAGUCHEK XS RESULT WAS REPORTED AND NO ADVERSE EVENT OCCURRED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264419 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21637422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 069 YR | METFORMIN| COUMADIN| AVILAD| LIPITOR |