FDA Adverse Event
Malfunction
Summary report: N
I-STAT ACTK (KAOLIN) CARTRIDGE
MDR report key: 2137375
·
Received May 31, 2011
Report
- Report Number
- 2245578-2011-00079
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 30, 2011
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- JBP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED A DELAY IN OBTAINING RESULTS WITH AN I-STAT ACT KAOLIN CARTRIDGE. THE CARTRIDGE WAS RUNNING AND THE ANALYZER TIMED OUT AFTER 15 MINUTES ON THREE OCCASIONS. ON (B)(6) 2011, A PATIENT WAS UNDERGOING AN ELECTROPHYSIOLOGY PROCEDURE AND ACT WAS BEING PERFORMED EVERY 15 MINUTES. THE FOLLOWING RESULTS (IN SECONDS) WERE OBTAINED: 227, 277, >1000, 340, 315, 340, >1000, 350, 365, 365, 340, >1000.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT ACTK (KAOLIN) CARTRIDGE | ACTK CARTRIDGE | JBP | ABBOTT POINT OF CARE CANADA LTD. | NA | S11082B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |