BD FACS¿ SAMPLE PREP ASSISTANT
Received Mar 9, 2023 · Event occurred Feb 21, 2023
Report 2916837-2023-00066 · MDR key 16513774
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00066 WAS SENT IN ERROR.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED BACK, SPOKE TO AND SHE EXPLAINED THAT WHEN THE SAMPLES ARE DONE RUNNING THEY ARE VERY CLOUDY AND IF THEY LET THEM SIT FOR A FEW MINUTES, THE RBC'S WILL SETTLE TO THE BOTTOM AND DO NOT APPEAR TO BE LYSED. I ASKED IF THEY ARE GETTING ANY ERROR MESSAGES AND THEY ARE NOT. NOT LYSING RED CELLS.
Additional Manufacturer Narrative
COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. INITIAL REPORTER ADDRESS 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED BACK, SPOKE TO AND SHE EXPLAINED THAT WHEN THE SAMPLES ARE DONE RUNNING THEY ARE VERY CLOUDY AND IF THEY LET THEM SIT FOR A FEW MINUTES, THE RBC'S WILL SETTLE TO THE BOTTOM AND DO NOT APPEAR TO BE LYSED. I ASKED IF THEY ARE GETTING ANY ERROR MESSAGES AND THEY ARE NOT. NOT LYSING RED CELLS.