FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1903034
·
Received November 12, 2010
Report
- Report Number
- 2027969-2010-01941
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 12, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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:" 6.9, 1.2, 3.4. THEY RECEIVED ALL THREE OF THESE RESULTS WITHIN 9 MINUTES OF EACH OTHER. RESULTS= 6.9, 1.2, 3.4. THE TESTS WERE RUN ON THE SAME METER WITH THE SAME STRIPS, PERFORMED BY THE SAME TECHNICIAN. RESULTS 6.9 AND 1.2 WERE ON SEPARATE FINGERS WHILE RESULT 3.4 WAS DONE ON THE SAME FINGER AS RESULT 1.2. CUSTOMER WAS ASKED TO RUN 4 TESTS ON NORMAL PATIENT'S NOT ON COUMADIN. THE RESULTS WERE AS FOLLOWS: 0.9, 1.0, 1.1 AND 1.0. ALL RESULTS FELL WITHIN NORMAL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 234586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |