FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3162601
·
Received June 11, 2013
Report
- Report Number
- 1823260-2013-03507
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 12, 2013
- Report Date
- August 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
- CO, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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 2.4 INR ON THE COAGUCHEK XS SYSTEM AND THAT SHE WAS HAVING ANOTHER TRANSIENT ISCHEMIC ATTACK (TIA). THE CALLER TOOK HER TO THE EMERGENCY ROOM (ER) WHILE A COMPARISON LAB RETURNED AS 1.9 INR TWO HOURS LATER. NO MEDICAL TREATMENT WAS REQUIRED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263353 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21625121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 072 YR | LASIX| LAMICTAL| TIMOLOL EYE DROPS| VITAMIN B12 TAB| VITAMIN D TAB| OXYGEN 2% VIA NASAL CANNULA| ESCITALOPRAM| POTASSIUM| COUMADIN| BACLOFEN| XALATAN EYE DROPS |