BD FACSLYRIC¿
Received Sep 18, 2023 · Event occurred Sep 5, 2023
Report 2916837-2023-00183 · MDR key 17769428
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
659180
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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) , ANSWER HAS BEEN PROVIDED (B)(6) . 1. COULD YOU PLEASE SHARE MDR SAFETY CHECKLIST OF PATIENT SAMPLES? WHEN I CREATED A CASE, I¿VE SUBMITTED ONLY CARRYOVER CHECKLIST, I¿VE FILLED UP NOW PATIENT SAMPLES IN SMAX. 2. COULD YOU PLEASE CONFIRM WHETHER THE CARRYOVER TOOK PLACE IN PATIENT SAMPLES? ACCORDING TO WHAT I HEARD, CUSTOMER USED PATIENT SAMPLE, BUT NOT THE WHOLE QUANTITY, WHEN HE NOTICED THE CARRYOVER ISSUE, HE MOVED TO ANOTHER INSTRUMENT. 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO PATIENT SAMPLES CHECKLIST) NO. CUSTOMER COMPLAINED ABOUT CARRYOVER ISSUE WITH THE INSTRUMENT, SIT FLUSH IS WORKING FINE, PROBE HAS NOT TOUCHED THE SAMPLE, LONG CLEAN HAD BEEN DONE YESTERDAY. NO ERROR MESSAGES. BUT ACCORDING TO THE CUSTOMER, THE PROBLEM HAPPENED AFTER LONG CLEAN.
Additional Manufacturer Narrative
BASED ON THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW, THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE UNEXPECTED RESULTS WAS DETERMINED TO BE A CLOG IN THE SHEATH FILTER. THE FSE REPLACED THE SHEATH FILTER AND SUBSEQUENT TESTING SHOWED THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE DIAGNOSED OR TREATED BASED ON ANY ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE 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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11-SEP, ANSWER HAS BEEN PROVIDED 08-SEP. 1. COULD YOU PLEASE SHARE MDR SAFETY CHECKLIST OF PATIENT SAMPLES? WHEN I CREATED A CASE, I¿VE SUBMITTED ONLY CARRYOVER CHECKLIST, I¿VE FILLED UP NOW PATIENT SAMPLES IN SMAX. 2. COULD YOU PLEASE CONFIRM WHETHER THE CARRYOVER TOOK PLACE IN PATIENT SAMPLES? ACCORDING TO WHAT I HEARD, CUSTOMER USED PATIENT SAMPLE, BUT NOT THE WHOLE QUANTITY, WHEN HE NOTICED THE CARRYOVER ISSUE, HE MOVED TO ANOTHER INSTRUMENT. 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO PATIENT SAMPLES CHECKLIST) NO. CUSTOMER COMPLAINED ABOUT CARRYOVER ISSUE WITH THE INSTRUMENT, SIT FLUSH IS WORKING FINE, PROBE HAS NOT TOUCHED THE SAMPLE, LONG CLEAN HAD BEEN DONE YESTERDAY. NO ERROR MESSAGES. BUT ACCORDING TO THE CUSTOMER, THE PROBLEM HAPPENED AFTER LONG CLEAN.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.