FDA Adverse Event
Other
Summary report: N
INRATIO
MDR report key: 1971712
·
Received January 12, 2011
Report
- Report Number
- 2027969-2011-00079
- Event Type
- Other
- Date Received
- January 12, 2011
- Date of Event
- December 19, 2010
- Report Date
- January 12, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
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: 6.5. DATE: (B)(6) 2010; INRATIO: 7.2; LAB: 4.4. DATE: (B)(6) 2010; INRATIO: 3.7; LAB: 3.2. PHYSICIAN STOPPED COUMADIN. CUSTOMER CALLED BACK WITH LAB RESULTS ON (B)(6) 2010. PHYSICIAN REQUESTED THAT PT INSTALL NEW, FRESH BATTERIES INTO METER AND REPEAT TESTING ON A DIFFERENT LOT OF STRIPS (234523). RESULT = 6.0. PT WAS ON ANTIBIOTIC; LAST DOSE WAS 1 WEEK AGO. PT NEEDS INR VALUE STABILIZED DUE TO HAND SURGERY SCHEDULED FOR NEXT WEEK. SELF-TEST ((B)(6) DAUGHTER) INR = 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 225433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |