FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1899441
·
Received November 9, 2010
Report
- Report Number
- 2027969-2010-01918
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- September 30, 2010
- Report Date
- November 9, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # 234130. INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 2.0, LAB: 4.0, DATE: (B)(6) 2010, 2.1, 6.0. ON (B)(6) 2010, PT WAS ADMITTED TO THE HOSPITAL AND GIVEN VITAMIN K. ON (B)(6) 2010, PT WAS ADMITTED TO THE HOSPITAL AGAIN BECAUSE HE WAS BLEEDING. PT'S THERAPEUTIC RANGE: 2-3 INR. PT'S DAUGHTER DID NOT KNOW WHICH LOT OF STRIPS WERE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| L| R |