FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2935160
·
Received January 14, 2013
Report
- Report Number
- 2027969-2013-00036
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 26, 2012
- Report Date
- January 14, 2013
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO RESULTS IN COMPARISON TO THE LAB RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 1.5, LABORATORY INR: 6.1. THE TIME BETWEEN TESTING WAS 1 HOURS. REPORTEDLY, THE FIRST DROP OF BLOOD WAS NOT USED, METER WAS NOT IN CORRECT MODE WHEN FINGER STICK PERFORMED AND IT TOOK LONGER THAN 15 SECONDS TO APPLY THE SAMPLE. THERAPEUTIC RANGE 2.0-3.0 FOR 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 |
|---|---|---|---|---|---|---|---|
| 21308 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 294387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ASPIRIN| WARFARIN| UNSPECIFIED HYPERTENSION MEDICATION| UNSPECIFIED DIABETIC MEDICATION| UNSPECIFIED PAIN MEDICATION |