FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2231291
·
Received July 25, 2011
Report
- Report Number
- 2027969-2011-01635
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 25, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PENDING. ADDITIONAL INFO D4: SERIAL# (B)(4).
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 7.1, LAB: 4.6. DATE: (B)(6) 2011, INRATIO: 4.9, INRATIO: 5.9. PT'S TARGET RANGE IS 2.0-3.0. COMPARED RESULTS DONE WITHIN MINUTES OF EACH OTHER. METER RESULT FROM (B)(6) 2011 WAS FROM METER# (B)(4). CALLER DID NOT SPECIFY WHICH RESULT WAS FROM METER# (B)(4) AND WHICH WAS FROM (B)(4) ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 251112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |