FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1942246
·
Received December 22, 2010
Report
- Report Number
- 2027969-2010-02243
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- October 2, 2010
- Report Date
- December 22, 2010
- 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
- SC, 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: PT 1, DATE: (B)(6) 2010, INR: 6.7, 2.8, 2.9. PT 2, DATE: (B)(6) 2010, >7.5, 3.4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 237431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |