FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1835699
·
Received September 9, 2010
Report
- Report Number
- 2027969-2010-01398
- Event Type
- Other
- Date Received
- September 9, 2010
- Date of Event
- August 18, 2010
- Report Date
- September 9, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
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) 2010, INRATIO: 1.8. DATE: (B)(6) 2010, INRATIO: >7.5, INRATIO2: >7.5. DATE: (B)(6) 2010, LAB: 7.3. REPEAT TESTING ON INRATIO2. ON (B)(6) 2010 TESTING USED STRIP LOT #234586. ON (B)(6) 2010 TESTING USED STRIP LOT #232886. PT WAS ADMITTED TO THIS FACILITY (B)(6); ON COUMADIN 5MG, ASPIRIN 325 MG, AND LOVENOX SUBQ 60 MG BID. ON MONDAY (B)(6) INR RESULTS USING STRIP LOT# 234586 WAS 1.8, DOSE WAS INCREASED TO COUMADIN 6MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 232886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |