FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2043575
·
Received March 25, 2011
Report
- Report Number
- 2027969-2011-00620
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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) 2011, INRATIO: 1.4, LAB: 2.8. PATIENT RECENTLY STARTED HEAVY DOSE OF UNDISCLOSED DRUG THAT CALLER BELIEVES MAY BE INTERFERING WITH TEST. PATIENT THERAPEUTIC RANGE IS 2.0-3.0. CALLER RESULTED INR OF 0.9 TESTING NURSE ON STAFF WHO IS NOT A COUMADIN USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 232888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |