FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2212933
·
Received July 12, 2011
Report
- Report Number
- 2027969-2011-01522
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- May 27, 2011
- Report Date
- July 12, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: ON (B)(6) 2011, PT FELL IN THE YARD AND BROKE AN OCCIPITAL CREST BONE IN THE FACE, RESULTING IN MASSIVE BLEEDING AND A BLOOD CLOT BEHIND THE EYE. LAB RESULT ON (B)(6) 2011 PROVED THAT HER INR WAS IN FACT LOW, SO PT WAS GIVEN TWO DOSES OF HEPARIN TO RAISED HER INR. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 241836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |