FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2864578
·
Received December 10, 2012
Report
- Report Number
- 1823260-2012-06214
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Date of Event
- October 30, 2012
- Report Date
- December 10, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. PATIENT 2, (B)(6)/1951. CALLER DID NOT KNOW WHICH METER PRODUCED THE DISCREPANT RESULTS. REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE ADDITIONAL SUSPECT DEVICE USED. WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: A 2.5 INR/1.99 INR. A 4.0 INR AND 4.0 INR/3.02 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM; HOWEVER, CALLER NO LONGER HAS THE TEST STRIPS; 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 | 21214611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 065 YR |