FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1899093
·
Received November 9, 2010
Report
- Report Number
- 2027969-2010-01921
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- October 18, 2010
- Report Date
- November 9, 2010
- 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
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH NURSE'S METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 2.7, NURSE'S METER: NG. (B)(6) 2010, 2.1, NG. (B)(6) 2010, NG, 1.6. (B)(6) 2010, 1.9, 1.4. PATIENT ALSO REPORTED GETTING 1.7, 1.8 AND 1.9 INR RESULTS, BUT WASN'T SURE WHICH METER THESE RESULTS WERE ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 231815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |