COAGUCHEK INRANGE
Report
- Report Number
- 1823260-2024-02982
- Event Type
- Malfunction
- Date Received
- October 15, 2024
- Date of Event
- September 3, 2024
- Report Date
- November 15, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K170960
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK INRANGE METER COMPARED TO A STAGO ST4 LABORATORY METHOD. ON 03-SEP-2024, THE METER RESULT WAS 4.8 INR.THE LABORATORY RESULT WAS 2.5 INR.ON 14-SEP-2024, THE METER RESULT WAS 5.2 INR.THE LABORATORY RESULT WAS 3.17 INR.THE TIME INTERVAL BETWEEN THE TESTS WAS NOT PROVIDED. THE PATIENT¿S THERAPEUTIC RANGE IS 2.5 - 3.5 INR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324038 | COAGUCHEK INRANGE | PROTHROMBIN TIME MONITOR | GJS | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CORDARON.| SIMVASTATINE.| SINTROM.| XATRAL.| ZOCOR. |