BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
Received Oct 17, 2023 · Event occurred Sep 27, 2023
Report 2916837-2023-00198 · MDR key 17953765
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
663029
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¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE STILL ISSUES WITH JUMPING MEASUREMENTS, ANT THE SAMPLE HAS TO BE RERUN IF THIS HAPPENS. HAZARD, INJURY OR ERRONEOUS RESULTS? YES.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: (B)(6). REPORTING OFFICE AND MANUFACTURING SITE CONTACT: (B)(6). H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF POTENTIAL ERRONEOUS RESULTS OF PATIENT SAMPLES WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR THE SAMPLES TO SHOW ERRONEOUS RESULTS WAS DUE TO CLOGGING OR OBSTRUCTION IN THE SAMPLE LINE BUT WAS CLEARED AFTER CLEANING AND CHANGING SAMPLE PREPARATION. THIS RESOLVED THE ISSUE AND THE INSTRUMENT IS RUNNING AS EXPECTED. DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. 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.
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¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE ARE STILL ISSUES WITH JUMPING MEASUREMENTS, ANT THE SAMPLE HAS TO BE RERUN IF THIS HAPPENS HAZARD, INJURY OR ERRONEOUS RESULTS? YES.