FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2068044
·
Received April 11, 2011
Report
- Report Number
- 2027969-2011-00782
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 19, 2011
- Report Date
- April 12, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: STRIP LOT #234130. DATE: (B)(6) 2011, INRATIO: 2.2, RE-TEST: 1.9, RE-TEST: 1.5. DIFFERENT FINGERS EACH TIME; ALL WITHIN 10 MINUTES. DATE: (B)(6) 2011, (B)(4) INRATIO: 1.9, (B)(4) INRATIO: 2.7. DIFFERENT FINGERS BOTH TIMES; TESTED WITHIN MINUTES. PATIENT IS NEW TO THE METER AND HAS BEEN ON COUMADIN SINCE (B)(6). PATIENT TAKES THEIR COUMADIN DOSE IN THE EVENINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 246050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |