FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 3072548
·
Received April 17, 2013
Report
- Report Number
- 2027969-2013-00308
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 19, 2013
- Report Date
- April 17, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO2 INR RESULTS IN COMPARISON TO AN UNSPECIFIED ALTERNATE TESTING INR RESULT. THE HOME HEALTH CARE SERVICES TESTED THE PT ON (B)(6) 2013 ON THE INRATIO2 AND RECEIVED A 2.8 INR READING. THE PT WENT TO SEE THE PHYSICIAN LATER THAT DAY DUE TO BLEEDING GUMS. THE PHYSICIAN TESTED ON AN UNSPECIFIED ALTERNATE TESTING SYSTEM AND RECEIVED A 6.0 INR RESULT. THE TIME BETWEEN TESTING WAS UNSPECIFIED. THERAPEUTIC RANGE 2.5-3.5 FOR PT. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165495 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 291558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | WARFARIN |