FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 2221232
·
Received August 15, 2011
Report
- Report Number
- 2027969-2011-01813
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- July 21, 2011
- Report Date
- August 15, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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: UNKNOWN, INRATIO: 2.3. DATE: UNKNOWN, LAB: 4.9. PATIENT HAD 2.3 RESULT ON METER THE DAY OF SURGERY IN (B)(6) OR (B)(6) 2011. PATIENT HAD BLEEDING FROM INCISION SITE THE FOLLOWING DAY AND WENT TO THE LAB WHERE INR WAS MEASURED AT 4.9. PATIENT HAS ALREADY HAD A METER REPLACEMENT DUE TO ERROR RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |