FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2063048
·
Received April 11, 2011
Report
- Report Number
- 2027969-2011-00769
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 14, 2011
- Report Date
- April 11, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB FOR PT #1 AS WELL AS IMPRECISION WITH INRATIO METER FOR PT #2. RESULTS AS FOLLOWS: PT #1: INRATIO - 4.7; LAB - 2.6 (10 MINUTES LATER). PT #2: 1ST INRATIO - 6.1; 2ND INRATIO - 4.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 235738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |