FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1899803
·
Received November 10, 2010
Report
- Report Number
- 2027969-2010-01931
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 19, 2010
- Report Date
- November 10, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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: DATE: (B)(6) 2010, INRATIO: 4.4, RE-TEST: 2.7, RE-TEST: ERROR, RE-TEST: 2.6. THE INITIAL TEST USED STRIP LOT #225433, RE-TESTS WERE DONE USING STRIP LOT #222167. PT HAS NO BLEEDING SYMPTOMS. CALLER REPORTED THAT SHE PERFORMED FINDER STICK BEFORE GREEN LIGHT WAS ON AND TOOK LONGER THAN 20 SECONDS TO APPLY THE SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 225433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |