FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2221513
·
Received August 24, 2011
Report
- Report Number
- 1823260-2011-04534
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 5, 2011
- Report Date
- September 12, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK XS SYSTEM (LOT NUMBER 20182931, EXPIRATION DATE 02/29/2012). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK S SYSTEM.
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED 2.3 INR ON THE COAGUCHEK S SYSTEM AND 1.5 INR ON THE COAGUCHEK XS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 | 20182931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR | HCTZ DAILY| TRAMADOL DAILY| NORVASC DAILY| COUMADIN DAILY| LORTAB| "COLI" STOOL SOFTENER 2/DAY |