FDA Adverse Event
Other
Summary report: N
SYSMEX SE-9000-ALPHA
MDR report key: 387015
·
Received April 4, 2002
Report
- Report Number
- 1422681-2002-00004
- Event Type
- Other
- Date Received
- April 4, 2002
- Date of Event
- March 4, 2002
- Report Date
- April 4, 2002
- Manufacturer
- SYSMEX CORPORATION
- Product Code
- GKZ
- Removal / Correction Number
- FCA 1422681-028-02-001C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE LAB SUPERVISOR REPORTED THAT ONE PT SAMPLE TUBE WAS ASPIRATED MULTIPLE TIMES DURING THE NIGHT SHIFT RUN. THE NIGHT-SHIFT OPERATOR PROCEEDED TO INCORRECTLY REPORT THE SAME POSITIVE RESULTS FOR MULTIPLE PATIENTS WITHOUT CONDUCTING APPROPRIATE FURTHER REVIEW. THE LAB SUPERVISOR ALSO REPORTED THAT TWO AFFECTED PATIENTS REC'D MEDICAL TREATMENT. HOWEVER, BOTH PATIENTS WERE REPORTED TO BE FINE, AND WERE DISCHARGED FROM THE HOSP WITHOUT ANY ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSMEX SE-9000-ALPHA | AUTOMATED HEMATOLOGY ANALYZER | GKZ | SYSMEX CORPORATION | SE-9000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |