FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3102966
·
Received May 9, 2013
Report
- Report Number
- 1823260-2013-02846
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 15, 2013
- Report Date
- June 5, 2013
- 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
- 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 4.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.0 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 |
|---|---|---|---|---|---|---|---|
| 203966 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21637512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 071 YR | LASIX| AMARYL| ALLOPURINOL| DETROL LA| FOSAMAX| KLOR-CON| VOLTAREN GEL| NITROGLYCERIN| LORTAB| METOPROLOL| ZOLOFT| ZANTAC| GABAPENTIN| ACTOS| FISH OIL| METFORMIN| COUMADIN DAILY |