FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2243698
·
Received July 28, 2011
Report
- Report Number
- 2027969-2011-01664
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 14, 2011
- Report Date
- July 28, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER (PT'S NURSE) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PT'S THERAPEUTIC RANGE: 2-3 INR. NURSE TRAINED PT ON (B)(6) 2011. PT'S DAUGHTER-IN-LAW WAS PRESENT FOR PT'S LAST TWO TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |