FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3851686
·
Received June 5, 2014
Report
- Report Number
- 1823260-2014-04048
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- April 4, 2014
- Report Date
- June 5, 2014
- 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
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CALLER TESTED 3.8 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.9 INR. NO TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, CUSTOMER NO LONGER HAS THE SUSPECT STRIPS TO RETURN. REPLACEMENTS WERE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328494 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22221921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 070 YR | FUROSEMIDE| MULTAQ| PROAIR HFA| MAGNESIUM OXIDE| ATORVASTATIN| SYMBICORT| LISINOPRIL| ATENOLOL| KLOR-CON| COUMADIN| PROBIOTIC| ALPRAZOLAM| CALTRATE |