FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2076171
·
Received March 31, 2011
Report
- Report Number
- 2027969-2011-00666
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 3, 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
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING. ADD'L LOT # 243934.
Description of Event or Problem · 1
CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.8 (STRIP LOT #247451). DATE: (B)(6) 2011, 5.0 (STRIP LOT #247451), 3.9 (STRIP LOT #243934). CALLER ALSO REPORTED LOW INRATIO RESULT. HOWEVER, IT WAS CONFIRMED BY THE LABORATORY. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.9, LAB: 1.9. PT HAD A LOVENOX INJECTION ON (B)(6) 2011 DUE TO THE LOW INR READING, WHICH WAS CONFIRMED BY THE LAB. 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 | 247451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |