FDA Adverse Event
Malfunction
Summary report: N
I-STAT CHEM 8+ CARTRIDGE
MDR report key: 1893951
·
Received November 3, 2010
Report
- Report Number
- 2245578-2010-00144
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- October 11, 2010
- Report Date
- November 3, 2010
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD
- Product Code
- JPI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 46%PCV. THE SAME SAMPLE, TESTED USING A LABORATORY INSTRUMENT YIELDED A HEMATOCRIT RESULT OF 24%PCV. A SECOND SAMPLE WAS TESTED ON THE I-STAT AND LABORATORY INSTRUMENT, WERE CONSISTENT WITH THE LABORATORY HEMATOCRIT RESULT OF 24%PCV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT CHEM 8+ CARTRIDGE | CHEM 8+ CARTRIDGE | JPI | ABBOTT POINT OF CARE CANADA LTD | C10229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |