BD FACSLYRIC¿
Received Jan 25, 2024 · Event occurred Jan 12, 2024
Report 2916837-2024-00003 · MDR key 18581940
Device
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 AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE RUN SAMPLES WITH THE LOADER, LESS SAMPLE IS PIPETTED THAN WHEN WE DO THIS VIA THE MANUAL CHANNEL. THE TEST CRITERIA ARE NOT MET IN THE LOADER. 5. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES 6. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 7. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 8. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO.
Additional Manufacturer Narrative
H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE SYSTEM NOT DETECTING VIABLE STEM CELLS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DHR WAS REVIEWED AND THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE FOR THE LOW SAMPLE VOLUME PIPETTED WITH THE LOADER WAS DUE TO THE LOADER AND STINGER BEING OUT OF ALIGNMENT. THE ISSUE WAS RESOLVED BY ADJUSTING THE LOADER CALIBRATION. 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 AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE RUN SAMPLES WITH THE LOADER, LESS SAMPLE IS PIPETTED THAN WHEN WE DO THIS VIA THE MANUAL CHANNEL. THE TEST CRITERIA ARE NOT MET IN THE LOADER. 5. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?: YES 6. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE?: NO 7. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT?: NO 8. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE?: NO.
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.