BD FACSLYRIC¿ 3L10C INSTRUMENT
Received Oct 17, 2023 · Event occurred Sep 21, 2023
Report 2916837-2023-00197 · MDR key 17953206
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. ERRONEOUS RESULTS WERE NOT OBTAINED, CUSTOMER REPORTED ERROR MESSAGES, THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT IN THE DEVELOPMENTAL PHASE OF BD FACSLYRIC¿ 3L10C INSTRUMENT ERROR MESSAGES OCCURRED ON SPECIMEN RUNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ACQUISITION OF OUR ONE OF OUR MULTI-WELL ASSAYS TWO ERRORS OCCURRED. THE FIRST OCCURRED WHEN MOVING ONTO THE NEXT WELL IN THE ASSAY WHICH STOPPED ACQUISITION COMPLETELY. THE SECOND ERROR OCCURRED ON COMPLETION OF ONE OF THE WELLS AND THEN THE SOFTWARE CRASHED. ¿LUCKILY THERE WAS NO IMPACT ALTHOUGH WE ARE STILL IN A DEVELOPMENT PHASE¿.
Description of Event or Problem
IT WAS REPORTED THAT IN THE DEVELOPMENTAL PHASE OF BD FACSLYRIC¿ 3L10C INSTRUMENT ERROR MESSAGES OCCURRED ON SPECIMEN RUNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ACQUISITION OF OUR ONE OF OUR MULTI-WELL ASSAYS TWO ERRORS OCCURRED. THE FIRST OCCURRED WHEN MOVING ONTO THE NEXT WELL IN THE ASSAY WHICH STOPPED ACQUISITION COMPLETELY. THE SECOND ERROR OCCURRED ON COMPLETION OF ONE OF THE WELLS AND THEN THE SOFTWARE CRASHED. ¿LUCKILY THERE WAS NO IMPACT ALTHOUGH WE ARE STILL IN A DEVELOPMENT PHASE¿.
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.