FDA Adverse Event
Other
Summary report: N
I-STAT1 SYSTEM MANUAL
MDR report key: 1582895
·
Received January 7, 2010
Report
- Report Number
- 2245578-2010-00003
- Event Type
- Other
- Date Received
- January 7, 2010
- Date of Event
- January 4, 2010
- Report Date
- January 7, 2010
- Manufacturer
- ABBOTT POINT OF CARE
- Product Code
- JBP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG# 06F20-01.
Description of Event or Problem · 1
A REMEDIAL ACTION HAS BEEN INITIATED TO UPDATE PRODUCT LABELING. THROUGH AN INTERNAL INVESTIGATION, ABBOTT POINT OF CARE OBSERVED DIFFERENCES IN HEMATOCRIT VALUES DEPENDING ON THE PITCH ANGLE OF THE I-STAT ANALYZER WHEN RUN WITH LOW HEMATOCRIT SAMPLES <30% PCV THAT APPEARED TO HAVE AN ELEVATED ERYTHROCYTE SEDIMENTATION RATE. THE I-STAT SYSTEM MANUALS WILL BE UPDATED TO INCLUDE STATEMENTS REGARDING THE AFFECT OF ANALYZER ANGLE ON CERTAIN BLOOD SAMPLES WITH A HIGH SEDIMENTATION RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT1 SYSTEM MANUAL | I-STAT1 SYSTEM MANUAL | JBP | ABBOTT POINT OF CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |