FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1776319
·
Received July 22, 2010
Report
- Report Number
- 2027969-2010-01022
- Event Type
- Malfunction
- Date Received
- July 22, 2010
- Date of Event
- June 23, 2010
- Report Date
- July 22, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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: 2.2, DOCTOR'S METER: 1.6, LAB: 1.4. PATIENT RESULTS ARE USUALLY BETWEEN 2.0-3.0. NO ANEMIA. NO CANCER/KIDNEY/LIVER ISSUES. NO HEPARIN/LOVENOX/ANTI-BIOTICS. NO AUTO-IMMUNE DISEASES/APS/LUPUS. NO AMIODARONE. NO THYROID ISSUES. USES 21G LANCETS. NOT DIFFICULT TO GET THE BLOOD OUT AND WAS APPLIED RIGHT AWAY. STRIP CODE IN METER DOES MATCH STRIP CODE ON OUTSIDE OF BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100071 | 218917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |