FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2942377
·
Received February 4, 2013
Report
- Report Number
- 1823260-2013-00645
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 4, 2013
- Report Date
- March 22, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE EVALUATED BY MFR: WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CALLER TESTED 6.1 INR AND 6.5 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.15 INR. CALLER STATES SHE WAS TAKEN TO THE HOSPITAL AFTER RECEIVING THE COAGUCHEK XS RESULTS. CALLER INITIALLY REPORTED RECEIVING COUMADIN AS WELL AS AN UNSPECIFIED INJECTION IN HER STOMACH, BUT THE FOLLOWING DAY THE CALLER DENIED HAVING ANY MEDICAL TREATMENT. 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 |
|---|---|---|---|---|---|---|---|
| 47046 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 066 YR | ARTIFICIAL KNEE| COUMADIN |