FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 3060878
·
Received April 10, 2013
Report
- Report Number
- 2027969-2013-00290
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 14, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL INR = 7.5; REPEAT INR = 0.7. PT SELF TESTER CALLED IN AFTER TESTING TODAY. INITIAL INRATIO INR = 7.5. REPEAT INR = <0.7. PT SELF TESTER STATED THAT SHE USED A DIFFERENT FINGER FOR EACH TEST. TESTS WERE PERFORMED WITHIN A FEW MINUTES OF EACH OTHER. PT THERAPEUTIC RANGE = 2.0 - 3.0. PT WAS MILKING FINGER AFTER FINGER STICK; ADDED MULTIPLE DROPS OF BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149919 | INRATIO2 | PROTHROMBINE TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 300667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LONG TIME.| LAST WEEK| PT IS ON OTHER MEDICATIONS BUT DID NOT WANT TO| WARFARIN| STATE WHAT THEY WERE BUT SHE HAS BEEN ON THEM A| PT STARTED TAKING ANTIBIOTICS FOR A FOOT INJURY |