FDA Adverse Event
Other
Summary report: N
I-STAT ACT KAOLIN CARTRIDGE
MDR report key: 795030
·
Received November 22, 2006
Report
- Report Number
- 2245578-2006-00028
- Event Type
- Other
- Date Received
- November 22, 2006
- Date of Event
- November 1, 2006
- Report Date
- November 22, 2006
- Manufacturer
- ABBOTT POINT OF CARE INC.
- Product Code
- JJE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT# R06245.
Description of Event or Problem · 1
ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO STATED THAT A PATIENT RECEIVED FIVE UNITS OF PACKED RED BLOOD CELLS OVER A PERIOD OF THREE DAYS FOLLOWING A CARDIAC CATHETERIZATION PROCEDURE. THE PATIENT WAS ADMINISTERED A TOTAL OF 10,000 UNITS OF HEPARIN DURING THE PROCEDURE. THE PATIENT'S HIGHEST ACT RESULT USING I-STAT ACT KAOLIN CARTRIDGE WAS 192 SECONDS WHICH WAS LOWER THAN EXPECTED BY THE CLINICIAN AND BELOW THEIR TARGET RANGE OF 200-225 SECONDS. THIS PATIENT WAS ALSO TREATED WITH A GPIIA-IIIB INHIBITOR, EPTIFIBATIDE (INTEGRILIN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT ACT KAOLIN CARTRIDGE | IVD | JJE | ABBOTT POINT OF CARE INC. | NA | R06237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |