BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING BD FACS SAMPLE PREP ASSISTANT III. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? THE SAMPLES WERE PATIENTS SAMPLES, BUT THE ERRONEOUS TUBES HAVE BEEN DISCARDED AND PREPARED AGAIN MANUALLY. NO IMPACT ON PATIENTS. THE PREPARER DOES NOT DISPENSE THE SAMPLE OR ONE OF THE REAGENTS RANDOMLY. THE NEEDLE AND SYRINGE HAVE BEEN REPLACED TWICE ALREADY.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: R0587 PROBLEM STATEMENT: CUSTOMER REPORTED: SPA DOES NOT DISPENSE SAMPLE/REAGENT MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE(B)(6) 2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THIS ARE 2 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: PROBLEM VISION, 1 ML SYRINGE AND RELATIVE VALVE REPLACED, INSTRUMENT PERFORMANCE CHECKED, SAMPLE PREPARATION TEST PERFORMED WITH POSITIVE RESULT. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #02118351 INSTALL DATE: (B)(6) 2021 DEFECTIVE PART NUMBER: 642439 ¿ VALVE 3-PORT XLP, 647348-SPA SYRINGE 1ML WORK ORDER NOTES: SUBJECT / REPORTED: SPA DOES NOT DISPENSE SAMPLE/REAGENT. PROBLEM DESCRIPTION: INCOMPLETE SAMPLE. CAUSE: VALVE ¿ SYRINGE PUMP. WORK PERFORMED: REPLACED VALVE AND SYRINGE PUMP. SOLUTION: REPLACED VALVE AND SYRINGE. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF 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 DEFECTIVE VALVE AND SYRINGE PUMP CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING BD FACS SAMPLE PREP ASSISTANT III. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? THE SAMPLES WERE PATIENTS SAMPLES, BUT THE ERRONEOUS TUBES HAVE BEEN DISCARDED AND PREPARED AGAIN MANUALLY. NO IMPACT ON PATIENTS. THE PREPARER DOES NOT DISPENSE THE SAMPLE OR ONE OF THE REAGENTS RANDOMLY. THE NEEDLE AND SYRINGE HAVE BEEN REPLACED TWICE ALREADY.

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.