FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2270288
·
Received August 25, 2011
Report
- Report Number
- 2027969-2011-01887
- Event Type
- Malfunction
- Date Received
- August 25, 2011
- Date of Event
- May 11, 2011
- Report Date
- August 25, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.4, LAB: 3.0. METER AND LAB TESTING WAS DONE WITHIN 30 MINUTES. PT SELF TESTERS SISTER CALLED IN; SISTER IS A REGISTERED NURSE. PT HAS NOT TESTED USING INRATIO SINCE AUGUST 2010 DUE TO HER BEING IN THE HOSPITAL FOR MULTIPLE MEDICAL CONDITIONS, INCLUDING A NEWLY DIAGNOSED BREAST CANCER AND BONE CANCER. PT HAS NOT BEEN IN THE HOSPITAL SINCE MARCH 2011.
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 |