BD FACSCANTO¿ II FLOW CYTOMETER
Received Jan 30, 2024 · Event occurred Jan 9, 2024
Report 2916837-2024-00008 · MDR key 18610708
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
338960
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE ISSUE WITH SAMPLE FLOW WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE OF THE ISSUE WITH THE SAMPLE FLOW WAS FLOW CELL MISALIGNMENT. THE DHR WAS REVIEWED TO CONFIRM THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A FIELD VISIT. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A REPAIR ON THE OPTICAL SUBSYSTEM OF THE INSTRUMENT. THIS INCLUDES ADJUSTING THE FLOW CELL AND ALIGNING THE LASER. AFTER THE ADJUSTMENTS PERFORMED, THE INSTRUMENT WAS TESTED AND CONFIRMED TO BE PERFORMING ACCORDING TO THE INSTRUMENT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH SAMPLE FLOW. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO, CLIENT USED BACK-UP SYSTEM.
Additional Manufacturer Narrative
H.3. 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 AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH SAMPLE FLOW ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO, CLIENT USED BACK-UP SYSTEM