BD FACSLYRIC¿
Report
- Report Number
- 2916837-2024-00013
- Event Type
- Malfunction
- Date Received
- February 2, 2024
- Date of Event
- January 23, 2024
- Report Date
- March 28, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- UDI-DI
- 00382906630292
- PMA / PMN Number
- K201814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED G.6. DATE RECEIVED BY MANUFACTURER: 03/28/2024. H.6. INVESTIGATION SUMAMRY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE BV 421 ISSUES WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW. THE INVESTIGATION WAS PERFORMED, AND THE POTENTIAL CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED, BUT CUSTOMER SUSPECTS SOMETHING WENT WRONG DURING YEARLY MAINTENANCE. THE ISSUE WAS RESOLVED WITH UPDATES TO CQC, LNW/LW, AND ADDING FLUOROCHROMES TWICE. THE FSE CONFIRMED THE INSTRUMENT IS RUNNING AS EXPECTED WITH NO FURTHER ERRONEOUS RESULTS. TECHNICALLY THERE IS NO ISSUE. APPLICATION SUPPORT WILL STAY IN TOUCH WITH CUSTOMER. 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.
H.6. INVESTIGATION SUMMARY: BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW COMPLAINT WAS CONFIRMED. THE INVESTIGATION WAS PERFORMED AND THE POTENTIAL CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED, BUT CUSTOMER SUSPECTS SOMETHING WENT WRONG DURING YEARLY MAINTENANCE. THE ISSUE WAS RESOLVED WITH UPDATES TO CQC, LNW/LW, AND ADDING FLUOROCHROMES TWICE. THE FSE CONFIRMED THE INSTRUMENT IS RUNNING AS EXPECTED WITH NO FURTHER ERRONEOUS RESULTS. TECHNICALLY THERE IS NO ISSUE. APPLICATION SUPPORT WILL STAY IN TOUCH WITH CUSTOMER. 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.
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.
IT WAS REPORTED THAT BD FACSLYRIC¿ ERRONEOUS RESULTS OCCURRED. NO PATIENT IMPACT IS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON FRIDAY (B)(6) 2024, ONE OF OUR ANALYSTS INFORMED US THAT HE OBSERVED AN INCREASED INTENSITY FOR THE BV421 SIGNAL IN ONE OF OUR ASSAYS. THIS INCREASED INTENSITY WAS OBSERVED FOR ALL SAMPLES STARTING FROM (B)(6) 2024 ONWARDS, WHICH IS THE DAY WHEN MAINTENANCE WAS PERFORMED ON BOTH INSTRUMENTS. WE HAVE RUN THE SAME SAMPLES ON ONE OF OUR OTHER INSTRUMENTS, AND THERE WE OBSERVE INTENSITIES COMPARABLE TO THE GRAPHS ON THE LEFT. BESIDES THIS, WE NOTICED THAT AFTER PERFORMING THE REQUIRED UPDATES (CQC, LNW/LW UPDATES, ADD FLUOROCHROMES), THE COMPENSATION MATRIX SHOWED A VERY HIGH VALUE (ABOUT 600%) FOR COMPENSATION BETWEEN EFLUOR506 AND BV421 AND V450. WE PERFORMED ALL UPDATES ONCE AGAIN, AND THEN THE ISSUE WAS RESOLVED. HOWEVER, KNOWING THAT WE ARE NOW EXPERIENCING THE ABOVE-MENTIONED TROUBLES WITH THE BV421 SIGNAL INTENSITY, WE SUSPECT SOMETHING WENT WRONG DURING THE YEARLY MAINTENANCE OF BOTH INSTRUMENTS.
IT WAS REPORTED THAT BD FACSLYRIC¿ ERRONEOUS RESULTS OCCURRED. NO PATIENT IMPACT IS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON FRIDAY 26JAN2024, ONE OF OUR ANALYSTS INFORMED US THAT HE OBSERVED AN INCREASED INTENSITY FOR THE BV421 SIGNAL IN ONE OF OUR ASSAYS. THIS INCREASED INTENSITY WAS OBSERVED FOR ALL SAMPLES STARTING FROM 23JAN2024 ONWARDS, WHICH IS THE DAY WHEN MAINTENANCE WAS PERFORMED ON BOTH INSTRUMENTS. WE HAVE RUN THE SAME SAMPLES ON ONE OF OUR OTHER INSTRUMENTS, AND THERE WE OBSERVE INTENSITIES COMPARABLE TO THE GRAPHS ON THE LEFT. BESIDES THIS, WE NOTICED THAT AFTER PERFORMING THE REQUIRED UPDATES (CQC, LNW/LW UPDATES, ADD FLUOROCHROMES), THE COMPENSATION MATRIX SHOWED A VERY HIGH VALUE (ABOUT 600%) FOR COMPENSATION BETWEEN EFLUOR506 AND BV421 AND V450. WE PERFORMED ALL UPDATES ONCE AGAIN, AND THEN THE ISSUE WAS RESOLVED. HOWEVER, KNOWING THAT WE ARE NOW EXPERIENCING THE ABOVE-MENTIONED TROUBLES WITH THE BV421 SIGNAL INTENSITY, WE SUSPECT SOMETHING WENT WRONG DURING THE YEARLY MAINTENANCE OF BOTH INSTRUMENTS.
IT WAS REPORTED THAT BD FACSLYRIC¿ ERRONEOUS RESULTS OCCURRED. NO PATIENT IMPACT IS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON FRIDAY 26JAN2024, ONE OF OUR ANALYSTS INFORMED US THAT HE OBSERVED AN INCREASED INTENSITY FOR THE BV421 SIGNAL IN ONE OF OUR ASSAYS. THIS INCREASED INTENSITY WAS OBSERVED FOR ALL SAMPLES STARTING FROM (B)(6) 2024 ONWARDS, WHICH IS THE DAY WHEN MAINTENANCE WAS PERFORMED ON BOTH INSTRUMENTS. WE HAVE RUN THE SAME SAMPLES ON ONE OF OUR OTHER INSTRUMENTS, AND THERE WE OBSERVE INTENSITIES COMPARABLE TO THE GRAPHS ON THE LEFT. BESIDES THIS, WE NOTICED THAT AFTER PERFORMING THE REQUIRED UPDATES (CQC, LNW/LW UPDATES, ADD FLUOROCHROMES), THE COMPENSATION MATRIX SHOWED A VERY HIGH VALUE (ABOUT 600%) FOR COMPENSATION BETWEEN EFLUOR506 AND BV421 AND V450. WE PERFORMED ALL UPDATES ONCE AGAIN, AND THEN THE ISSUE WAS RESOLVED. HOWEVER, KNOWING THAT WE ARE NOW EXPERIENCING THE ABOVE-MENTIONED TROUBLES WITH THE BV421 SIGNAL INTENSITY, WE SUSPECT SOMETHING WENT WRONG DURING THE YEARLY MAINTENANCE OF BOTH INSTRUMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256164 | BD FACSLYRIC¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 00382906630292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |