FDA Adverse Event
Other
Summary report: N
CELL-DYN 3000SL
MDR report key: 293533
·
Received August 28, 2000
Report
- Report Number
- 2919069-2000-00017
- Event Type
- Other
- Date Received
- August 28, 2000
- Report Date
- August 25, 2000
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELL DYN
- Product Code
- GKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCOUNT REPORTED A PLATELET COUNT OF 62,000 ON AN EMERGENCY ROOM PT. THE ACCOUNT HAD INFORMED THE EMERGENCY ROOM THAT THE RESULT WAS NOT CONFIRMED AND THEY WOULD BE CALLING WITH THE CONFIRMED RESULT. THE SLIDE WAS REVIEWED WHICH SHOWED A PLATELET COUNT OF LESS THAN 8,000. THE EMERGENCY ROOM WAS CONTACTED WITH THIS RESULT. THE PHYSICIAN WAS ALREADY PLANNING TO TRANSFUSE THE PT WITH 4 UNITS OF PLATELETS BASED ON CLINICAL PRESENTATION OF THE PT. NO INJURY REPORTED. THE ACCOUNT WAS UNWILLING TO PROVIDE FURTHER INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-DYN 3000SL | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELL DYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |