FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2102451
·
Received May 19, 2011
Report
- Report Number
- 2027969-2011-01114
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 19, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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:" 2.0 AND 1.5. CUSTOMER TESTED TODAY AND GOT A RESULT OF 2.0 ON LOT 243934. THIS SEEMED LOW TO HER, SO SHE RE-TESTED A FEW MINUTES AFTERWARD ON HER NEW BOX OF STRIPS, LOT 247451, AND GOT A RESULT OF 1.5. BOTH TESTS DONE WITH FRESH FINGERSTICKS. CUSTOMER TYPICALLY HAS AN INR THAT IS MUCH HIGHER, AS HER THERAPEUTIC RANGE IS 3.0-4.0 (PATIENT GETS BLOOD CLOTS EASILY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |