FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1913787
·
Received November 23, 2010
Report
- Report Number
- 2027969-2010-02047
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 18, 2010
- Report Date
- November 23, 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
- 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. CALLER ALSO ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 4.0, LAB: 3.1. PT NOTED THAT HE HAD BEEN EATING CRANBERRY SAUCE AROUND THE TIME OF THE DISCREPANCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |