FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3162624
·
Received June 11, 2013
Report
- Report Number
- 1823260-2013-03504
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- March 18, 2013
- Report Date
- June 11, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CALLER TESTED 5.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.1 INR. NO ACTIONS TAKEN BASED TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER THE CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263358 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 051 YR | CONTROLLED-RELEASE MORPHINE| LOVENOX| LANTUS| COMPAZINE| LIFELINE BRACELET| TRAZODONE| FLAXSEED/FISH OIL| ATENOLOL| PROZAC| OXYCODONE| VENTOLIN INHALER| DIABETIC SUPPLEMENTS| ALBUTEROL| XANAX| UNK ACCUCHEK GLUCOMETER| NEBULIZER| WARFARIN |