FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3050540
·
Received March 11, 2013
Report
- Report Number
- 2027969-2013-00205
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 11, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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:" - INRATIO 2.8, RETEST 2.3, RETEST 1.3. THERAPEUTIC RANGE: 2-3. TIME BETWEEN TESTS: 5 MINUTES. TESTING WAS PERFORMED USING THE SAME FINGER; MILKING FINGER AFTER FINGER STICK. THE METER WAS NOT IN THE CORRECT MODE WHEN FINGER STICK WAS PERFORMED AND IT TOOK LONGER THAN 15 SECONDS TO APPLY THE SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102514 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 299622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ORAL ANTICOAGULANTS COUMADIN |