FDA Adverse Event
Other
Summary report: N
CELL-DYN 1600 CS
MDR report key: 536313
·
Received March 4, 2004
Report
- Report Number
- 2919069-2004-00008
- Event Type
- Other
- Date Received
- March 4, 2004
- Report Date
- March 2, 2004
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELLDYN
- Product Code
- GKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED THE FOLLOWING HEMOGLOBIN RESULTS ON THE CELL-DYN 1600 ANALYZER: 7.9, 7.4, 6.7 AND 10.1 G/DL. NO RESULTS WERE REPORTED FROM THE LAB. THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE A HEMOGLOBIN RESULT OF 10.6 G/DL WAS GENERATED (PLATFORM UNKNOWN). THE CUSTOMER STATES THAT WHEN THE CELL-DYN 1600 ANALYZER WAS POWERED ON THREE DAYS LATER, THE ANALYZER BACKGROUND COUNTS WERE OUT OF SPECIFICATIONS AND THE PREMIX CUP WAS NOT DRAINING PROPERLY. THE CUSTOMER ALSO NOTICED BLACK DEBRIS IN THE TUBING CONNECTING INTO A T-FITTING. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-DYN 1600 CS | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELLDYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |