FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2399473
·
Received January 5, 2012
Report
- Report Number
- 1823260-2012-00112
- Event Type
- Malfunction
- Date Received
- January 5, 2012
- Date of Event
- December 27, 2011
- Report Date
- January 25, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, 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 5.8 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 10.0 INR. PATIENT'S COUMADIN DOSES WERE HELD BASED ON THE LAB VALUE AND HE WAS PRESCRIBED ONE DOSE OF VITAMIN K. 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 | 20751511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 070 YR | LOMOTIL| ALLOPURINOL DAILY| LOPID TWICE DAILY| "CULTUREL" DAILY| LANTUS AT NIGHT| NEURONTIN 3 TIMES DAILY| NORVASC DAILY| LISINOPRIL DAILY| ASPIRIN DAILY| COUMADIN| NIASPAN TWICE DAILY |