BD FACS¿ SAMPLE PREP ASSISTANT III
Received Jan 18, 2024 · Event occurred Oct 9, 2023
Report 2916837-2024-00001 · MDR key 18539507
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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN "WO-03192403" IT HAS BEEN STATED AS "SAMPLE CARRYOVER IN PIPETTING" AS PART OF COMPLIANCE REVIEW COULD YOU PLEASE ANSWER THE FOLLOWING SAFETY QUESTIONS 1. WAS THE CARRYOVER OBSERVED IN PATIENT SAMPLES? A: YES, IT WAS OBSERVED IN PATIENT SAMPLES. SYSTEM PIPETTING FAILURE.
Additional Manufacturer Narrative
D.2. COMMON DEVICE NAME:: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR. H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE "SYSTEM PIPETTING FAILURE" WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE WAS DUE TO A MISALIGNED PROBE WHICH WAS REPLACED, AND SUBSEQUENT TESTS WERE CARRIED OUT WITH NO ISSUES OBSERVED. 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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN "(B)(4)" IT HAS BEEN STATED AS "SAMPLE CARRYOVER IN PIPETTING" AS PART OF COMPLIANCE REVIEW COULD YOU PLEASE ANSWER THE FOLLOWING SAFETY QUESTIONS 1. WAS THE CARRYOVER OBSERVED IN PATIENT SAMPLES? A: YES, IT WAS OBSERVED IN PATIENT SAMPLES. SYSTEM PIPETTING FAILURE.