FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 3884165
·
Received May 19, 2014
Report
- Report Number
- 2027969-2014-00451
- Event Type
- Malfunction
- Date Received
- May 19, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 28, 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 LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT AND PHYSICIAN INRATIO INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 1.6, LABORATORY INR: 3.7, PHYSICIANS INRATIO INR: 2.2. THE TIME BETWEEN TESTING WAS TEN (10) MINUTES. REPORTEDLY, MULTIPLE FINGER STICKS PERFORMED ON THE SAME FINGER AND THE SAMPLE WAS NOT APPLIED IMMEDIATELY AFTER THE FINGER STICK. THERAPEUTIC RANGE 2.0 -3.0 FOR THE PT. THERE WAS NO ADVERSE EVENT REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295582 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO INC | 100071 | 315105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNSPECIFIED HBP MEDICATION| INRATIO MONITOR SN: (B)(4)| MULTIVITAMIN,| CALCIUM| UNSPECIFIED ANTIBIOTICS.| LEVOTHYROXINE| VITAMINS AND/OR SUPPLEMENT CENTRUM SILVER 50+| WARFARIN |