FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1972963
·
Received January 20, 2011
Report
- Report Number
- 2027969-2011-00150
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 31, 2010
- Report Date
- January 20, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULT WITH METER COMPARED TO LAB: DATE: (B)(6) 2010, INRATIO2: 5.2, LAB: 2.6. RESULTS DONE WITHIN 30 MINUTES OF EACH OTHER. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. PATIENT'S HEMATOCRIT ON (B)(6) 2011 WAS 37.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 241836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |