BD FACSVIA¿ FLOW CYTOMETER
Received Nov 9, 2023 · Event occurred Oct 27, 2023
Report 2916837-2023-00217 · MDR key 18098342
Device
Generic name
Flow Cytometric Reagents And Accs
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
656874
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 DURING USE WITH BD FACSVIA¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: IN THE APC HISTOGRAM WE OBSERVE A NEGATIVE POPULATION THAT SHOULD NOT BE THERE. THE QC PASSED WITHOUT ANY PROBLEMS. 1. 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. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - (B)(4). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF UNEXPECTED POPULATIONS WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THE FSE PERFORMED A SERIES OF REPAIRS AND TROUBLESHOOTING TECHNIQUES BUT FAILED TO RESOLVE THE ISSUE. THE INSTRUMENT WAS DE-INSTALLED AND REPLACED BY ANOTHER FACSVIA INSTRUMENT. NO ONE WAS HARMED OR INJURED, AND THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT. REVIEW OF THE DHR CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. 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.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. 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 DURING USE WITH BD FACSVIA¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: IN THE APC HISTOGRAM WE OBSERVE A NEGATIVE POPULATION THAT SHOULD NOT BE THERE. THE QC PASSED WITHOUT ANY PROBLEMS. 1. 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. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO.