FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2000220
·
Received February 18, 2011
Report
- Report Number
- 2027969-2011-00366
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 18, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: 1.0, LAB: 4.0. NURSE TESTED PATIENT IN THE HOME AND THEN WENT TO THE LAB WITHIN 30 MINUTES. CUSTOMER IS NOT SURE WHICH METER THIS OCCURRED ON SO THEY PROVIDED TWO SERIAL NUMBERS. PATIENT HAD NO BLEEDING, OR BRUISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 237433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |