FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3230078
·
Received July 16, 2013
Report
- Report Number
- 1823260-2013-04286
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 10, 2013
- Report Date
- October 25, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE THE PRODUCT WAS LOST IN SHIPPING TO THE INVESTIGATIVE UNIT.
Description of Event or Problem · 1
CALLER TESTED 3.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.3 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 |
|---|---|---|---|---|---|---|---|
| 329713 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21912021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 047 YR | FISH OIL ONCE DAILY| BABY ASPIRIN ONCE DAILY| LIPITOR ONCE DAILY| COUMADIN ONCE DAILY| GEMFIBROZIL TWICE DAILY| ARTIFICIAL "HEART" VALVE| COQ10 ONCE DAILY| LEVOTHYROXINE DAILY| FUROSEMIDE| METOPROLOL TWICE DAILY |