FDA Adverse Event
Malfunction
Summary report: N
I-STAT CHEM8+ CARTRIDGE
MDR report key: 1991485
·
Received January 28, 2011
Report
- Report Number
- 2245578-2011-00018
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- December 10, 2010
- Report Date
- January 28, 2011
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 THAT AN I-STAT CHEM8+ CARTRIDGE YIELDED UNEXPECTED RESULTS FOR SODIUM, CHLORIDE AND HEMATOCRIT. THE SAME SAMPLE WAS TESTED ON (B)(6), 2010 ON THE I-STAT AT 09:30 AND IN THE LABORATORY AT 13:21: I-STAT RESULTS: SODIUM 109, LAB RESULTS: 142. I-STAT RESULTS: CHLORIDE 120, LAB RESULTS: 106. I-STAT RESULTS: HEMATOCRIT 21, LAB RESULTS: 32.2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT CHEM8+ CARTRIDGE | CHEM8+ CARTRIDGE | JJE | ABBOTT POINT OF CARE CANADA LTD. | NA | C10247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |