FDA Adverse Event
Malfunction
Summary report: N
BD SAMPLE PREP ASSISTANT II
MDR report key: 1594586
·
Received February 1, 2010
Report
- Report Number
- 2916837-2010-00001
- Event Type
- Malfunction
- Date Received
- February 1, 2010
- Date of Event
- January 4, 2010
- Report Date
- February 1, 2010
- Manufacturer
- BD BIOSCIENCES
- Product Code
- GKZ
- PMA / PMN Number
- K050191
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
USING AN AUTOMATED SAMPLE PREP ASSISTANT DEVICE, A CUSTOMER REPORTED THAT AN INCORRECT RESULT WAS REPORTED OUT OF THE LAB TO A HCP AT 4 PM AND CORRECTED AT 10 AM THE NEXT DAY. THE QC REPORT STATED THAT IT "COULD NOT ACQUIRE THE USER REQUESTED NUMBER OF LYMPHOCYTES MANUAL GATE IS IN EFFECT." THE LAB COMPLETED THE MANUAL PIPETTING THE NEXT DAY. THE POTENTIAL HEALTH HAZARD HAS BEEN DETERMINED TO BE LOW DUE TO INACCURATE SAMPLE DISPENSE. THE LIMITATIONS OF THE DESIGN OF THE SAMPLE PREP ASSISTANT DEVICE ALLOWS FOR INADEQUATE SAMPLE DISPENSING UP TO 0.5% OF 720 SAMPLES AS STATED IN THE USER'S GUIDE. THE USER'S GUIDE ALSO STATES TO REVIEW THE DATA AND ANY QC GENERATED COMMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD SAMPLE PREP ASSISTANT II | BD SPA II | GKZ | BD BIOSCIENCES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |