BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
Received Oct 19, 2023 · Event occurred Sep 25, 2023
Report 2916837-2023-00201 · MDR key 17968360
Device
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 FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(4); G.1 - MANUFACTURING SITE CONTACT - (B)(4); G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE COULD NOT BE DETERMINED. HOWEVER, THE FSE PERFORMED A THOROUGH CHECK AND RE-ALIGNED THE OPTICS, AND EVERYTHING WAS WELL WITHIN RANGE. THIS RESOLVED THE ISSUE, AND THE INSTRUMENT IS RUNNING AS EXPECTED. DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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 BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS ARE BEING OBTAINED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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
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. 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 BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS ARE BEING OBTAINED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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.