FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1972967
·
Received January 20, 2011
Report
- Report Number
- 2027969-2011-00141
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 20, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULT WITH METER: DATE: (B)(6) 2010, INRATIO: 0.9, RETEST INRATIO: 1.4. RETEST WAS DONE WITHIN MINUTES OF INITIAL RESULT. PATIENT SELF TESTER WENT OFF COUMADIN ON (B)(6) 2010 FOR A COLONOSCOPY PROCEDURE. PATIENT RECEIVED LOVENOX INJECTIONS FOR 3 DAYS. COUMADIN WAS RESTARTED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |