BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
Received Mar 28, 2025 · Event occurred Mar 12, 2025
Report 3027394506-2025-00010 · MDR key 21719506
Device
Generic name
Flow Ctyometric Reagents And Acessories
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
335775
Lot number
85587
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. ADDITIONAL PMA / 510(K)#: K040026, K040725, K050191, K062087. 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 WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS AN INCORRECT RESULT WAS REPORTED OUT TO A PHYSICIAN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY DECIDED TO RUN THE SAMPLES AFTER THE PASS WITH THE EXPIRED BEADS. THEY SHOULD NOT HAVE REPORTED THE RESULTS BECAUSE OF THE EXPIRED 7 COLOR SET UP BEADS, AND UNFORTUNATELY THE RESULTS WERE USED FOR INCLUSION/EXCLUSION IN A STUDY. CUSTOMER CONFIRMED THAT THERE WAS NO HARM, NEGATIVE IMPACT, OR INJURY TO THE PATIENT AS FAR AS THEY KNOW.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS AN INCORRECT RESULT WAS REPORTED OUT TO A PHYSICIAN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY DECIDED TO RUN THE SAMPLES AFTER THE PASS WITH THE EXPIRED BEADS. THEY SHOULD NOT HAVE REPORTED THE RESULTS BECAUSE OF THE EXPIRED 7 COLOR SET UP BEADS, AND UNFORTUNATELY THE RESULTS WERE USED FOR INCLUSION/EXCLUSION IN A STUDY. CUSTOMER CONFIRMED THAT THERE WAS NO HARM, NEGATIVE IMPACT, OR INJURY TO THE PATIENT AS FAR AS THEY KNOW.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF QC FAILURE WHICH CAUSED ERRONEOUS RESULTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: COMPLAINT HISTORY REVIEW: THE POTENTIAL CAUSE WAS DUE TO THE USE OF EXPIRED BEADS. THE FIELD SERVICE ENGINEER (FSE) ALSO CONFIRMED THAT ALTHOUGH THE LOT NUMBER WAS CORRECT THE TARGET VOLTAGES WERE ALL SET TO DEFAULT AND THE SPECTRAL OVERLAPS WERE ALSO SET TO 100. THE FSE INPUTTED THE CORRECT VALUES AND THE ISSUE WAS RESOLVED.