FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1942312
·
Received December 22, 2010
Report
- Report Number
- 2027969-2010-02234
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Report Date
- December 22, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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: OCTOBER, INRATIO: 1.7. DATE: (B)(4) 2010, INRATIO: 1.7 INRATIO: 2.5. DATE: (B)(4) 2010, LAB: 2.4. PT SELF TESTER RECEIVED A 1.7 ON HIS INRATIO METER, AND THE DISTRIBUTOR RECEIVED A 2.5 ON THEIR INRATIO METER. TESTING WAS DONE AT THE SAME TIME WITH THE SAME FINGER USING ONE FINGER STICK. THE NEXT DAY ON (B)(4) 2010, THE PT GOT A LAB DRAW AND THE RESULT WAS 2.4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 234880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |