FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® S SYSTEM
MDR report key: 2482455
·
Received March 7, 2012
Report
- Report Number
- 1823260-2012-01274
- Event Type
- Malfunction
- Date Received
- March 7, 2012
- Date of Event
- February 2, 2012
- Report Date
- March 28, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JPA
- PMA / PMN Number
- K974569
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER STATES PATIENT TESTED >8.0 INR ON THE COAGUCHEK S SYSTEM WHILE A COMPARISON LAB RETURNED AS 5.0 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 ® S SYSTEM | PROTHROMBIN TIME TEST STRIPS | JPA | ROCHE DIAGNOSTICS | NA | 963A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 083 YR | COUMADIN |