FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1377594
·
Received March 6, 2009
Report
- Report Number
- 2027969-2009-00089
- Event Type
- Malfunction
- Date Received
- March 6, 2009
- Date of Event
- February 16, 2009
- Report Date
- March 5, 2009
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- JPA
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS REPORTABLE BECAUSE A RECURRENCE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. DEVICE WILL NOT BE RETURNED FOR EVAL. INVESTIGATION IS PENDING.
Description of Event or Problem · 1
CALLER REPORTED RESULTS DISCREPANCY BETWEEN INRATIO AND LAB. (B) (6) 2009: INR METER 1.2, INR LAB 2.2. METER INR 1.5. ONE DAY LATER 2.1. INR METER 2.1 INR 1.5 AND 1.0 WEEK LATER. PT ALSO RECEIVED ERRORS: NES, 141, 114.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | BIOSITE INCORPORATED | 0100007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |