FDA Adverse Event
Injury
Summary report: N
INRATIO2
MDR report key: 2850264
·
Received November 15, 2012
Report
- Report Number
- 2027969-2012-01612
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- October 16, 2012
- Report Date
- November 15, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 2.5, LAB: 8.8. TWO HRS IN BETWEEN METER AND LAB TESTING. PT HAD AN UNCONTROLLED NOSE BLEED WHICH LED PT TO GO TO THE ER AND HAVE LAB DRAW. CUSTOMER HAS THREE INRATIO METERS AND DOES NOT KNOW WHICH METER WAS USED TO OBTAIN PT RESULTS. REFERENCE MDR NUMBERS 2027969-2012-01611 AND 2027969-2012-01613 FOR OTHER METERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 284365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |