FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1954261
·
Received December 9, 2010
Report
- Report Number
- 2027969-2010-02136
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- November 17, 2010
- Report Date
- December 9, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH ANOTHER POC METER. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2010, INRATIO #1: 7.5, DIFFERENT POC METER: 1.8. (B)(6) 2010, 7.5, INRATIO #2: 1.5. COMPARISON WERE FROM TWO DIFFERENT PATIENT SAMPLES, PERFORMED WITHIN ONE HOUR OF ONE ANOTHER, AND USING THE SAME STRIP LOT NUMBER WHEN COMPARING METER 1 TO METER 2. CUSTOMER HAS TWO INRATIO METERS IN THEIR OFFICE. VENOUS BLOOD BEING USED FOR ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 235738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |