BD FACSCANTO¿ II
Received Feb 1, 2024 · Event occurred Jan 23, 2024
Report 2916837-2024-00009 · MDR key 18620400
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338962
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
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 DURING USE WITH THE BD FACSCANTO¿ II . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO. THE CUSTOMER REPORTED THE RESULTS ARE NOT AS EXPECTED. THE QC PASSED FINE. THE CUSTOMER DID SEVERAL CLEANINGS AND PURGES, BUT PROBLEM PERSISTS.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE SYSTEM PRODUCING ERRONEOUS RESULTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE DHR WAS REVIEWED AND THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE FOR THE ERRONEOUS RESULTS WAS A FAULTY SHEATH REGULATOR. AFTER THE REPLACEMENT OF THIS COMPONENT AND A LASER ALIGNMENT, THE INSTRUMENT WAS PERFORMING AS EXPECTED. 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 ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO. THE CUSTOMER REPORTED THE RESULTS ARE NOT AS EXPECTED. THE QC PASSED FINE. THE CUSTOMER DID SEVERAL CLEANINGS AND PURGES, BUT PROBLEM PERSISTS.