BD FACSLYRIC¿ 3L10C INSTRUMENT
Received Feb 22, 2024 · Event occurred Feb 6, 2024
Report 2916837-2024-00016 · MDR key 18762985
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 DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT CARRYOVER OCCURRED INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CARRYOVER OF RESIDUAL POPULATIONS BETWEEN SAMPLES.
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.
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE FOR THE SAMPLE CARRYOVER ISSUE WAS FROM A BAD PINCH VALVE HOSE AND POOR ADJUSTMENT OF SIT PIPE BUT WAS SOLVED BY CHANGING THE SILICONE HOSE AND ADJUSTING THE SIT PIPE WITH THE ADJUSTMENT TOOL. THIS RESOLVED THE ISSUE, AND THE INSTRUMENT IS RUNNING AS EXPECTED. 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 DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT CARRYOVER OCCURRED INVOLVING PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CARRYOVER OF RESIDUAL POPULATIONS BETWEEN SAMPLES.