BD FACSCANTO¿ II
Received Sep 21, 2023 · Event occurred Sep 13, 2023
Report 2916837-2023-00185 · MDR key 17796011
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338962
Lot number
NA
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
Description of Event or Problem
IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSCANTO¿ II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES 2. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES REPORTING OFFICE CONTACT:(B)(6)- MDR MANUFACTURING OFFICE CONTACT: (B)(6) - MDR H.6: BASED ON THE COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW, THE REPORTED 'ISSUE WITH FLOWRATE' WAS NOT CONFIRMED, AND THE POTENTIAL CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING FLOW RATE ISSUE. TO RESOLVE THE ISSUE, FSE PERFORMED TRUCOUNT BEADS TEST AND FOUND THAT FLOW RATE IS WITHIN SPECIFICATIONS AND INSTRUMENT IS FUNCTIONING AS INTENDED. THE SAFETY RISK OF THIS HAZARD IS DEEMED TO BE WITHIN ACCEPTABLE CRITERIA. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED . INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED TO DETERMINE IF FURTHER ACTION IS NEEDED . OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSCANTO¿ II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? 2. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? THE CUSTOMER REPORTED IT TAKES TWICE AS LONG TO ACQUIRE A SAMPLE AND THE VALUES ARE ABOUT TWICE TOO HIGH. THE FLOW RATE IS TOO SLOW IN ANY FLOW RATE MODE AND EVENT RATE TOO HIGH. THE POPULATIONS LOOK THE SAME, NO DEBRIS VISIBLE, THERE ARE MORE EVENTS. THE THRESHOLD IS OK AND THE SAMPLES ARE DILUTED LIKE BEFORE THE ISSUE.