BD FACSLYRIC¿
Received Sep 19, 2024 · Event occurred Aug 26, 2024
Report 2916837-2024-00047 · MDR key 20258636
Device
Generic name
Flow Cytometric Reagents And Accessories
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
663029
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 ERRONEOUS RESULTS OCCURRED DURING USE WITH THE BD FACSLYRIC¿, AND WERE REPORTED TO A CLINICIAN. MDR SAFETY CHECKLIST: PATIENT SAMPLES: DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. CUSTOMER REPORTED ABOUT BAD RESULTS.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ERRONEOUS RESULTS WAS NOT CONFIRMED. BASED ON THE CUSTOMERS REPORT OF AN INCIDENT OF ERRONEOUS RESULTS, AN FSE WAS DEPLOYED ONSITE TO TROUBLESHOOT THE ISSUE. UPON RUNNING TESTS ON THE INSTRUMENT, NO ISSUE COULD BE FOUND. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED. 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 E.1. INITIAL REPORTER ADDRESS 1: (B)(6). 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 OCCURRED DURING USE WITH THE BD FACSLYRIC¿ AND WERE REPORTED TO A CLINICIAN. MDR SAFETY CHECKLIST ¿ PATIENT SAMPLES: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. YES 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. YES, CUSTOMER REPORTED ABOUT BAD RESULTS.