FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2390797
·
Received December 9, 2011
Report
- Report Number
- 2027969-2011-02488
- Event Type
- Malfunction
- Date Received
- December 9, 2011
- Date of Event
- November 18, 2011
- Report Date
- December 9, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL INR = 4.6; 2ND INR = 3.5; 3RD INR = 1.5. PT SELF TESTER USED SAME FINGER STICK FOR 2 OF THE 3 READINGS (WASN'T SURE WHICH). PT'S THERAPEUTIC RANGE IS 2.5-3.5. STRIPS EXPIRED 08/2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 237431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |