BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THE INSTRUMENT TAKES TOO LITTLE OF A SAMPLE, THEREFORE ERRONEOUS RESULTS CAN OCCUR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS AN ONGOING, VERY INFREQUENT ISSUE WITH THE INSTRUMENT WHERE NO / TOO LITTLE SAMPLE IS TAKEN. THE CUSTOMER HAS A PROCEDURE IN PLACE TO DOUBLE-CHECK THE RESULTS FROM THE INSTRUMENT BEFORE REPORTING THEM. FILTER IS CLEANED EVERY MORNING, AND THE PROBE IS REPLACED EVERY 1000 TESTS (INSTEAD OF EVERY 2000). ALTHOUGH THE CUSTOMER HAS A METHOD IN PLACE TO DOUBLE-CHECK THE RESULTS OF THE INSTRUMENT (WITH A SEPARATE HAEMATOLOGY LYMPH COUNT), THERE IS THE POSSIBILITY OF THE GENERATION OF ERRONEOUS RESULTS.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6) PROBLEM STATEMENT: CUSTOMER REPORTED: SPA HAS A INTERMITTENT PIPETTING ERROR MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 22MAR2020 TO DATE 22MAR2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THIS IS THE ONLY COMPLAINT RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 22MAR2020 TO DATE 22MAR2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE CUSTOMER REPORTS AN ONGOING, VERY INFREQUENT ISSUE WITH THE INSTRUMENT WHERE NO / TOO LITTLE SAMPLE IS TAKEN. THE CUSTOMER HAS A PROCEDURE IN PLACE TO DOUBLE CHECK THE RESULTS FROM THE INSTRUMENT BEFORE REPORTING THEM. PRIMED SYSTEM, PERFORMED ACCURACY AND PRECISION TESTING, OBTAIN MEAN VALUE OF 51.0MG (RANGE IS 48.5-51.6) %CV =1.11 PASSING RANGE IS <=3%, NO ISSUE ERROR. NO FAULT FOUND. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4) INSTALL DATE: 21NOV2017 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: INTERMITTENT PIPETTING ERROR PROBLEM DESCRIPTION: CANNOT BE DETERMINED CAUSE: UNDETERMINED WORK PERFORMED: RUN A&P. VERIFY SYSTEM IS PERFORMING PER SPEC SOLUTION: NO PROBLEM FOUND RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR PART NUMBER: 647205 AND SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES NO.HAZARD ID: 3.1.42 _ HAZARD: INACCURATE DISPENSE SEVERITY: 2 PROBABILITY: 1 RISK INDEX: 2 IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ RISK CONTROL: ALARP MITIGATION(S) SUFFICIENT YES NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE ROOT CAUSE WAS UNDETERMINED CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: NA. 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 WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THE INSTRUMENT TAKES TOO LITTLE OF A SAMPLE, THEREFORE ERRONEOUS RESULTS CAN OCCUR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS AN ONGOING, VERY INFREQUENT ISSUE WITH THE INSTRUMENT WHERE NO / TOO LITTLE SAMPLE IS TAKEN. THE CUSTOMER HAS A PROCEDURE IN PLACE TO DOUBLE-CHECK THE RESULTS FROM THE INSTRUMENT BEFORE REPORTING THEM. FILTER IS CLEANED EVERY MORNING, AND THE PROBE IS REPLACED EVERY 1000 TESTS (INSTEAD OF EVERY 2000). ALTHOUGH THE CUSTOMER HAS A METHOD IN PLACE TO DOUBLE-CHECK THE RESULTS OF THE INSTRUMENT (WITH A SEPARATE HAEMATOLOGY LYMPH COUNT), THERE IS THE POSSIBILITY OF THE GENERATION OF ERRONEOUS RESULTS.