BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
Received Oct 17, 2023 · Event occurred Sep 25, 2023
Report 2916837-2023-00199 · MDR key 17953726
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
663029
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
Additional Manufacturer Narrative
G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. D.4. MEDICAL DEVICE EXPIRATION DATE. 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 FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO DELAY IN TREATMENT OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CD34 COUNT IS DIFFERENT FROM THAT OF THE OTHER FACSLYRIC INSTALLED IN THE SAME LABORATORY THESE ARE PATIENT SAMPLES BUT THERE WAS NO NEGATIVE IMPACT EITHER IN TERMS OF DELAY IN DIAGNOSIS OR TREATMENT.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(4). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE REGARDING UNEXPECTED CD34 COUNT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR UNEXPECTED CD34 COUNT WAS FAULTY GEL COUNT CHAMBER AND ALIGNMENT ISSUE. THE CUSTOMER REPORTED A COMPLAINT REGARDING UNEXPECTED CD34 COUNT. THE CD34 COUNT IN THE INSTRUMENT WAS DIFFERENT THAN THAT OF THE OTHER FACSLYRIC INSTALLED IN THE SAME LABORATORY. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT. THEY REPLACED THE GEL COUNTING CHAMBER AND ALIGNED THE FSC/OPTICS. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS PERFORMING AS INTENDED. 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 DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO DELAY IN TREATMENT OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CD34 COUNT IS DIFFERENT FROM THAT OF THE OTHER FACSLYRIC INSTALLED IN THE SAME LABORATORY THESE ARE PATIENT SAMPLES BUT THERE WAS NO NEGATIVE IMPACT EITHER IN TERMS OF DELAY IN DIAGNOSIS OR TREATMENT.