FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1905925
·
Received November 15, 2010
Report
- Report Number
- 2027969-2010-01957
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 15, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING. ADD'L LOT #: 234130.
Description of Event or Problem · 1
CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 1.6. DATE: (B)(6) 2010, INR: 3.8 (STRIP LOT #218916), 4.6 (STRIP LOT #234130), 3.7 (DURING RETRAINING). ON (B)(6) 2010: DOCTOR ADJUSTED PT'S COUMADIN DOSE: INCREASED DOSE FROM 5 MG TO 6 MG, THEN DECREASED TO 5.6 MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 218916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |