FDA Adverse Event
Other
Summary report: N
CD 3000 CS
MDR report key: 440616
·
Received January 31, 2003
Report
- Report Number
- 2919069-2003-00002
- Event Type
- Other
- Date Received
- January 31, 2003
- Date of Event
- December 30, 2002
- Report Date
- January 30, 2003
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELL DYN
- Product Code
- GKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 12/20/2002 THE ACCOUNT RAN A PT SAMPLE 4 TIMES IN THE OPEN MODE OF THE CD3000. PER THE ACCOUNT THE FOLLOWING HEMOGLOBIN (HGB) RESULTS WERE GENERATED: 14.9 G/DL, 7 G/DL,13.2 G/DL, 7 G/DL. THE ACCOUNT STATED THAT THEY REPORTED 8.2 G/DL FOR THE HGB. THE PT WAS TRANSFUSED WITH ONE UNIT OF BLOOD. THE SAMPLE WAS REPEATED AND THE HGB WAS 14.2 G/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD 3000 CS | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELL DYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |