BD FACSLYRIC¿
Received May 3, 2024 · Event occurred Apr 17, 2024
Report 2916837-2024-00029 · MDR key 19240399
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
659180
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. 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¿ CARRYOVER OCCURRED WITH PATIENT SAMPLES. THERE WAS A COUPLE HOUR DELAY ON TEST RESULTS, HOWEVER, THE ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER REPORTS THAT THERE IS CARRY OVER FROM ONE TUBE TO ANOTHER.
Additional Manufacturer Narrative
THE FOLLOW FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H6.: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER BETWEEN TUBES WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE CLOGGED TUBING. THE FSE INVESTIGATED THE ISSUE AND PROVIDED REMOTE SUPPORT FOR ADJUSTING THE TUBING, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED. DHR REVIEW IS NOT REQUIRED AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. 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¿ CARRYOVER OCCURRED WITH PATIENT SAMPLES. THERE WAS A COUPLE HOUR DELAY ON TEST RESULTS, HOWEVER, THE ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER REPORTS THAT THERE IS CARRY OVER FROM ONE TUBE TO ANOTHER.