FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2000605
·
Received February 2, 2011
Report
- Report Number
- 2027969-2011-00242
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 5, 2011
- Report Date
- February 2, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.8, LAB: NG; (B)(6) 2011: NG, 2.6. PT HAS BEEN USING THE INRATIO METER FOR 7 YEARS. HE HAD A PROCEDURE PERFORMED ON (B)(6) 2011, SO HE DID NOT TAKE COUMADIN THE NIGHT BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |