FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2076170
·
Received March 31, 2011
Report
- Report Number
- 2027969-2011-00668
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 5, 2011
- Report Date
- March 31, 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
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING. ADD'L LOT # 243103.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 5.5, 5.3. NURSE PERFORMED TESTS ON (B)(6) 2011 AND PT PERFORMED TESTS ON (B)(6) 2011 AND (B)(6) 2011. 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 | 234526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |