FDA Adverse Event
Injury
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 2141071
·
Received June 27, 2011
Report
- Report Number
- 1823260-2011-03465
- Event Type
- Injury
- Date Received
- June 27, 2011
- Date of Event
- May 27, 2011
- Report Date
- June 28, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 2.0 INR ON THE COAGUCHEK XS SYSTEM. PATIENT WAS TAKEN TO THE HOSPITAL COMPLAINING OF PAIN; A LAB VALUE RETURNED AS 11.6 INR APPROXIMATELY 6.5 HOURS AFTER PATIENT'S METER RESULT OF 2.0 INR. PATIENT WAS TREATED WITH VITAMIN K AND ADMITTED TO THE HOSPITAL FOR 3 DAYS. CALLER NOTED PATIENT WAS MISSING 8-9 COUMADIN TABLETS; CALLER BELIEVES PATIENT INADVERTENTLY TOOK COUMADIN INSTEAD OF HER PAIN MEDICATION. PATIENT AND PATIENT'S FAMILY HAVE DENIED THIS. PATIENT'S CONDITION HAS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE 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 | 20183231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 080 YR | Hospitalization| R | OXYCONTIN "IR"| PRILOSEC| TYLENOL| NASONEX DAILY| "ALLERGY" EYE DROPS| CPM MACHINE| MEDROXYPROGESTERONE| "ESTROGEN"| MOISTURIZING EYE DROPS| COUMADIN| WALKER| LISINOPRIL DAILY| CLARINEX DAILY |