FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 2132487
·
Received June 8, 2011
Report
- Report Number
- 2027969-2011-01279
- Event Type
- Injury
- Date Received
- June 8, 2011
- Date of Event
- May 7, 2011
- Report Date
- June 8, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT#: 243934. INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, LOT 243104 INRATIO: 3.8, (B)(4), INRATIO: 4.8, LAB: 1.8, LOT 243934 INRATIO: 5.0. PT'S TARGET THERAPEUTIC RANGE IS 2.5 - 3.0. PT PRESENTED IN EMERGENCY ROOM ON (B)(6) 2011 WITH EDEMA AND LEG PAIN. PHYSICIAN DID SIDE BY SIDE COMPARISON BETWEEN METER AND LAB. PT WAS TREATED FOR ASTHMA AND SUB-THERAPEUTIC INR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |