FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2243842
·
Received July 29, 2011
Report
- Report Number
- 2027969-2011-01679
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 29, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011; INRATIO: >7.5; LAB: 1.7. PT IS UNSURE OF EXACT TARGET THERAPEUTIC RANGE BUT STATED THAT THEY LIKE TO KEEP HER INR AROUND 2.0-3.0. PT'S SON TOOK HER TO THE LAB WITHIN 20 MINS AND SHE HAD LAB DRAW DONE WITHIN AN HOUR OF THE METER RESULT.
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 |