FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIP
MDR report key: 3909518
·
Received June 10, 2014
Report
- Report Number
- 2027969-2014-00562
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 16, 2014
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGING RECEIVING DISCREPANT INRATIO VALUES. ON (B)(6) 2014, INRATIO2 2.1; CLINIC POC 7.1 AND 6.6. TIME BETWEEN THE TESTING - MINUTES. PTS' THERAPEUTIC RANGE 2.5 - 3.5. BASED ON CLINIC POC METER OF 7.1, PHYSICIAN RECOMMENDED PT TAKE VITAMIN K. IT IS UNK THE DATES PT RECEIVED VITAMIN K. NO ADD'L INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340352 | INRATIO PT/INR TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 332831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | WARFARIN| INRATIO MONITOR SERIAL #UNK |