FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIP
MDR report key: 3884175
·
Received May 19, 2014
Report
- Report Number
- 2027969-2014-00457
- Event Type
- Malfunction
- Date Received
- May 19, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 29, 2014
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO LOW INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 1.4; LABORATORY INR: 2.4. THE TIME BETWEEN TESTING WAS ONE (1) HOUR. REPORTEDLY, MILKING FINGER AFTER FINGER STICK, MONITOR NOT IN CORRECT MODE AND TOUCHED FINGER TO SAMPLE WELL. THERAPEUTIC RANGE 2.0 - 4.0 FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295579 | INRATIO PT/INR TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 334472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO MONITOR SN: (B)(4) |