BD FACSCANTO¿ II FLOW CYTOMETER
Received Dec 11, 2025 · Event occurred Nov 28, 2025
Report 3027394506-2025-00047 · MDR key 23778292
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
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04069 H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLES ASPIRATING VERY QUICKLY WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING SAMPLES ASPIRATING VERY QUICKLY LINKED TO TUBING IN THE FLUIDIC SYSTEM. TUBING WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE REPORTED TO A CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6). 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? YES 3. WAS THERE ANY CHANGE OR DELAY OF TREATMENT DUE TO THE ISSUE? NO BECAUSE THEY WILL RERUN THE SAMPLE ON THE SAME DAY AND NO DELAY FOR GENERATING THE CORRECT RESULTS ON TIME.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE REPORTED TO A CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE WILL BE ASPIRATED VERY FAST. 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? YES 3. WAS THERE ANY CHANGE OR DELAY OF TREATMENT DUE TO THE ISSUE? NO BECAUSE THEY WILL RERUN THE SAMPLE ON THE SAME DAY AND NO DELAY FOR GENERATING THE CORRECT RESULTS ON TIME.
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.