FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2211240
·
Received July 11, 2011
Report
- Report Number
- 2027969-2011-01517
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 8, 2011
- Report Date
- July 11, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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: 7.1, LAB: 1.9, DATE: (B)(6) 2011, INRATIO: 7.5, LAB: 1.8, DATE: LAST WEEK, INRATIO: >7.5, LAB: 1.9. TIME BETWEEN METER AND LAB TESTING IS ABOUT 20 MINUTES. PT REPORTS THAT HE OCCASIONALLY MILKS THE FINGER, BUT NOT MUCH. CUSTOMER HAS BEEN USING THIS LOT OF STRIPS SINCE (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 248203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |