FDA Adverse Event
Malfunction
Summary report: N
I - STAT ACTC (CELITE)
MDR report key: 2130268
·
Received May 9, 2011
Report
- Report Number
- 2245578-2011-00065
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 20, 2011
- Report Date
- May 6, 2011
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- JBP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 I-STAT ACT-CELITE CARTRIDGES WERE PRODUCING ERROR CODE 44 AND ERROR CODE 46. A PT WAS HAVING VENTRICULAR TACHYCARDIA ABLATION WHEN A NURSE TRIED TO RUN A BASELINE SAMPLE AND OBTAINED AN ERROR CODE 46. IN TOTAL, CUSTOMER REPORTED 7 ERROR CODE 46 RESULTS AND 1 ERROR CODE 44 RESULT OVER DIFFERENT PT SAMPLES WHICH CAUSED DELAYS IN OBTAINING TEST RESULTS. THERE WAS NO SERIOUS IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I - STAT ACTC (CELITE) | ACTC CARTRIDGE | JBP | ABBOTT POINT OF CARE CANADA LTD. | NA | S11066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |