FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2082598
·
Received April 27, 2011
Report
- Report Number
- 2027969-2011-00936
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- 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 DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.3, DOCTOR'S INRATIO2: 2.6, LAB: 2.3 PT SELF TESTER TESTED ON HIS DOCTOR'S INRATIO2 METER, HIS METER AND AT THE LAB. PT REPORTS THAT THE SAME FINGER STICK WAS USED FOR BOTH THE DOCTOR'S METER AND PT'S METER. TESTING WAS DONE THE SAME DAY WITHIN AN HOUR FROM THE LAB, A VENOUS SAMPLE WAS USED OF THE LAB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |