FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2992919
·
Received February 28, 2013
Report
- Report Number
- 2027969-2013-00173
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 28, 2013
- Manufacturer
- ALERE SAN DIEGO
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER ALLEGES PRECISION ISSUES. THERAPEUTIC RANGE: 2 - 3. INRATIO (LOT #296799) = 5.5. INRATIO (LOT #297451A)= 1.2. TESTS PERFORMED THREE HOURS APART. SEE MDR 2027969-2013-00172 FOR LOT # 297451A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86987 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO | 100071 | 296799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SINCE (B)(6) 2013 - ONLY HAS A FEW DOSES.| PST HAS BEEN TAKING SYNTHROID FOR YEARS AND IS| STABLE ON ALL OTHER MEDICATIONS.| WARFARIN| PST HAS BEEN ON AMOXICILLIN (FOR SINUSE INFECTION) |