FDA Adverse Event
Injury
Summary report: N
CD1800 ANALYZER
MDR report key: 728472
·
Received June 9, 2006
Report
- Report Number
- 2919069-2006-00037
- Event Type
- Injury
- Date Received
- June 9, 2006
- Report Date
- May 11, 2006
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELL DYN
- Product Code
- GKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS IN PROCESS.
Description of Event or Problem · 1
THE CONTROLS ON THE CELLDYN 1800 ANALYZER WERE OUT OF RANGE. THE ACCOUNT HAD REPORTED PATIENT RESULTS WITH CONTROLS OUT OF RANGE. FOR ONE PATIENT THE ACCOUNT REPORTED A MEMATOCRIT (HCT) OF 24.0%. THE SAMPLE WAS SENT TO THE HOSPITAL LAB WHICH OBTAINED A HCT OF 34.0%. THE ACCOUNT STATED THAT THE PATIENT WAS GIVEN A BLOOD TRANSFUSION BASED ON THE HCT RESULT 24.0%
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD1800 ANALYZER | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELL DYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |