FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2220096
·
Received August 12, 2011
Report
- Report Number
- 2027969-2011-01800
- Event Type
- Malfunction
- Date Received
- August 12, 2011
- Date of Event
- June 29, 2011
- Report Date
- August 12, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. DOSE HAS BEEN ADJUSTED SEVERAL TIMES DUE TO HIGH RESULTS ON METER. ON (B)(6) 2011, RESULT DONE WITH LOT #246050. DATA HAS NO COMPARATOR AND WOULD NOT BE REPORTABLE BY ITSELF, BUT HAS BEEN INCLUDED ON THIS REPORT IN AN EFFORT TO PROVIDE ALL AVAILABLE INFO. THE 4.1 RESULT ON (B)(6) 2011 WAS DONE WITH LOT #248203. THIS LOT WAS REPORTED ON MDR # 2027969-2011-01799, BUT HAS BEEN INCLUDED ON THIS REPORT BECAUSE THE TWO LOTS ARE BEING COMPARED TO ONE ANOTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |