FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2063053
·
Received April 11, 2011
Report
- Report Number
- 2027969-2011-00765
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 11, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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:" (B)(6) 2011: INR = 6.9; RETEST INR = 4.5. (B)(6) 2011: INR = 2.0; RETEST INR = 3.0. ON FRIDAY PT SKIPPED HER COUMADIN; ON SATURDAY SHE TOOK 1 MG; ON SUNDAY SHE TOOK 2 MG. SHE HAD BEEN TAKING 2 MG A DAY AND IT WAS CAUSING HER INR TO INCREASE. PT HAD NO BLEEDING OR ADDITIONAL BRUISING ON FRIDAY. THERAPEUTIC RANGE = 2.5 - 3.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |