FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2230946
·
Received July 20, 2011
Report
- Report Number
- 2027969-2011-01598
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 20, 2011
- Manufacturer
- ALERE SAN DIEGO INC
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.6, 1.9, LAB: 3.1, 3.1. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.6 (OLD STRIP LOT #248203), 1.9 (NEW STRIP LOT #254609). PT'S THERAPEUTIC RANGE: 2.5 - 3.5 INR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO INC | 100071 | 254609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |