BD FACSVIA¿ FLOW CYTOMETER
Received Dec 21, 2023 · Event occurred Nov 22, 2023
Report 2916837-2023-00232 · MDR key 18377944
Device
Generic name
Flow Cytometric Reagents And Accs
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
656874
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST ? YES. 2. WAS THERE AN ERROR MESSAGE ? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE ? YES. 4. IS THIS PRESTO ? NO. 656874 - BD FACSVIA FLOW CYTOMETER - THE CYTOMETER STOPPED BECAUSE BLUE LASER ERROR OCCURRED.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00232 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 ¿ ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST ? YES 2 ¿ WAS THERE AN ERROR MESSAGE ? YES 3- DID THE CUSTOMER BYPASS THE ERROR MESSAGE ? YES 4 ¿ IS THIS PRESTO ? NO 656874 - BD FACSVIA FLOW CYTOMETER - THE CYTOMETER STOPPED BECAUSE BLUE LASER ERROR OCCURRED.