BD ONEFLOW ALOT

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WITH PATIENT SAMPLES WITH A BD ONEFLOW¿ ALOT. THERE WAS NO DELAY IN TREATMENT, AND SAMPLES WERE NOT RE-DRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MPO FITC SPILLOVER INTO PE CHANNEL AND CD7 APC SPILLOVER INTO SCD3 APC-H7 IS NOT CORRECTLY COMPENSATED WHEN ACQUIRING DATA ON ONEFLOW A LOT TUBES AND ONEFLOW SETTINGS. BETWEEN, USER IS USING BD INTRASURE KIT FOR THE INTRACELLULAR STAINING ADDITIONALLY, ON 2020-07-10 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿ WAS THE PROBLEM OBSERVED ON A PATIENT SAMPLE INTENDED FOR CLINICAL USE? THE PROBLEM OBSERVED ON PATIENT SAMPLES. ¿ IF SO WAS THERE ANY IMPACT TO THE PATIENT? NO. THE USERS RUN BOTH AML PANEL AND T-ALL TO COUNTER CHECK THE RESULT OF ALOT SCREENING TUBE. ¿ WERE SAMPLES REDRAWN? NO. ¿ WAS THERE ANY DELAY IN TREATMENT? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY ¿ SCOPE OF ISSUE: THE SCOPE OF THIS COMPLAINT IS LIMITED TO CAT# 660228 - 0036701 ALOT CE-IVD KIT. ¿ PROBLEM STATEMENT: MPO FITC SPILLOVER INTO PE CHANNEL AND CD7 APC SPILLOVER INTO SCD3 APC-H7 IS NOT CORRECTLY COMPENSATED WHEN ACQUIRING DATA ON ONEFLOW A LOT TUBES AND ONEFLOW SETTINGS. BETWEEN, USER IS USING BD INTRASURE KIT FOR THE INTRACELLULAR STAINING. ¿ MANUFACTURING DEFECT TREND: FROM 21MAY2019 TO 21MAY2020, NO QN WAS GENERATED IN SAP FOR THE FOLLOWING MATERIALS: 660228 ¿ 0036701 ALOT KIT; 91-0996-9319811 POUCH ONEFLOW ALOT-S; 60-0799-9310197 RGNT ONEFLOW ALOT-S; 91-1006-9322750 POUCH ONEFLOW ALOT-C; 60-0811-9311205 RGNT ONEFLOW ALOT C. ¿ COMPLAINT TREND: THIS IS THE ONLY COMPLAINT RELATED TO CATALOG 663288 FROM 21MAY2019 TO 21MAY2020 . RELATED COMPLAINT (B)(4) IS FOR LOT 0036701. ¿ BATCH HISTORY RECORD REVIEW REVIEW THE PRODUCTION BATCH RECORDS FOR MATERIAL 663266-9365398 AND THE FOLLOWING IN-PROCESS MATERIALS THAT WAS PART OF THE ALOT KIT: 91-0996-9319811 POUCH ONEFLOW ALOT-S; 60-0799-9310197 RGNT ONEFLOW ALOT-S; 91-1006-9322750 POUCH ONEFLOW ALOT-C; 60-0811-9311205 RGNT ONEFLOW ALOT C. RESULT ON THE REVIEW OF THE HISTORICAL BATCH RECORDS OF THE MATERIALS SHOWED THAT ALL THE PRODUCTS HAD COMPLIED TO ALL THE QC ACCEPTANCE AND SPECIFICATION CRITERIA AS DESIGNED NEEDED TO RELEASE THE PRODUCT. ¿ RESULT OF RETAIN SAMPLE TESTING: TO TEST THE PERFORMANCE OF ALOT KIT 660228-0036701 REAGENT, A NORMAL PERIPHERAL BLOOD SPECIMEN WAS STAINED WITH THE RETAIN REAGENT SAMPLE FOLLOWING THE ALOT FIX/PERM STAINING PROCEDURE. STAINED SPECIMENS WAS ACQUIRED USING THE FOLLOWING INSTRUMENT AND SETUP: 1) CANTO II INSTRUMENT SETUP WITH THE BD SETUP BEADS PN# 658620- 8282578 TO CREATE APPLICATION SETTING, AND FCB PN# 658621-8302537 TO CREATE THE COMPENSATION SETUP. THE BEAD MATERIALS MENTIONED WERE THE SAME MATERIALS USED BY THE CUSTOMER TO SETUP THEIR INSTRUMENT THAT WAS USED TO ACQUIRE THE STAINED SPECIMEN AND HAD OBSERVED THE SPILLOVER ISSUES. IT IS NOTED, THAT THE BEADS WERE EXPIRED WHEN USED FOR IN-HOUSE COMPLAINT INVESTIGATION AND WHEN USED BY THE CUSTOMER. 2) CANTO II INSTRUMENT WITH ALL THE MATERIALS USED TO SETUP THE INSTRUMENT WERE WITHIN DATE. 3) LYRIC INSTRUMENT WITH ALL MATERIALS USED TO SETUP THE INSTRUMENT WERE WITHIN DATE AND USED THE BD ONEFLOW TUBE SETTING. THE TESTING WERE DONE TO IDENTIFY IF THE ISSUES OF SPILLOVER OF APC TO APCH7 AND FITC TO PE WERE CAUSED BY THE EXPIRED MATERIALS USED TO SETUP THE INSTRUMENT OR THE PERFORMANCE OF THE REAGENT ITSELF. FCS FILES FROM ACQUISITIONS FROM CANTO II AND LYRIC INSTRUMENTS WERE ANALYZED TO DETERMINE IF SPILLOVER ISSUES OBSERVED BY THE CUSTOMER WERE REPRODUCIBLE DURING THE INVESTIGATION. RESULTS OF THE DATA ANALYSIS: 1. APC SPILLOVER TO APCH7 WERE OBSERVED IN ALL THE FCS FILES COLLECTED FROM THE ABOVE MENTIONED INSTRUMENTS AND INSTRUMENT SETUP.. THE EXPIRED BEADS THAT WERE USED TO SET UP THE INSTRUMENTS WAS NOT A FACTOR TO CAUSE THE SPILLOVER ISSUE. IRRESPECTIVE OF INSTRUMENT OR INSTRUMENT SETUP USED DURING ACQUISITION, THE APC SPILLOVER TO APCH7 ON THIS SPECIFIC LOT OF ALOT REAGENT WAS CONFIRMED , . 2. FITC SPILLOVER TO PE WAS NOT OBSERVED. THE FITC SPILLOVER TO PE WAS NOT CONFIRMED. ¿ RESULT OF RETURNED SAMPLE EVALUATION: NO TASK WAS CREATED FOR THE RETURN OF THE SAMPLE. PICTURES CAN BE IN LIEU OF THE RETURNED SAMPLE. ¿ INVESTIGATION RESULT / ANALYSIS: BASED ON THE REVIEW OF THE PHOTO SUBMITTED BY THE CUSTOMER IN THE COMPLAINT AND THE RESULT OF THE RETAIN SAMPLE TESTING CONDUCTED IN HOUSE, IT WAS DETERMINED THAT THIS SPECIFIC LOT OF ALOT REAGENT HAVE SHOWN SIGNIFICANT APC SPILLOVER TO THE APCH7 CHANNEL. THEREFORE THE APC SPILLOVER TO APCH7 WAS CONFIRMED FOR THIS BATCH OF REAGENT. FITC TO PE SPILLOVER WAS NOT OBSERVED. THEREFORE THE FITC TO PE SPILLOVER IS NOT CONFIRMED. ¿ RISK ANALYSIS: REVIEWED RISK ANALYSIS DOCUMENT: SAP#10000241669 REVB, BD ONEFLOW ALOT RISK ANALYSIS. HAZARD(S) IDENTIFIED? YES. TFS ID53497. HAZARD #: 3.2 USE ERRORS. 3.2.7 INDIRECT HARM TO PATIENT. CAUSE: ALOT TUBE IS NOT COMPATIBLE WITH SOV MATRIX GENERATED BY FC BEADS. HARMFUL EFFECTS: INCORRECT COMPENSATION OF THE TANDEMS CAUSED. POPULATION TO BE . INCORRECTLY IDENTIFIED, RESULTING INCORRECT RESULT. PROBABILITY: 2. SEVERITY: 2. RISK INDEX: 4. INITIAL RISK EVALUATION: ACCEPTABLE. RISK CONTROL: INTERNAL VERIFICATION STUDY FOR ACCURACY OF A LOT USING BD FC BEAD SETUP METHODOLOGY. IMPLEMENTATION VERIFICATION: CLINICAL TRIAL ACCURACY STUDY INCLUDES SETUP USING FC BEADS VERSUS EF METHOD SINGLE STAINED CELLS. SYSTEM VERIFICATION ACCURACY STUDY PROTOCOL. EFMC-15-37P. EFMC-16-39P. MITIGATION(S) SUFFICIENT: YES. ¿ ATTACHED PICS/DOCS FROM INVESTIGATION: PIR# 11631045 INVESTIGATION RESULT PPP ATTACHMENT. ¿ INVESTIGATION CONCLUSION: RESULTS OF THE HISTORICAL BATCH RECORD INVESTIGATION SHOWED THAT THE PRODUCT COMPLIED AND PASSED ALL QC SPECIFICATIONS. RESULT OF RETAIN INVESTIGATION TEST, CONFIRMED THE CUSTOMER¿S OBSERVATION ON THE APC SPILLOVER INTO THE APCH7 CHANNEL FOR THIS SPECIFIC BATCH OF ALOT KIT REAGENT. FITC TO PE SPILLOVER ISSUE IS UNCONFIRMED. ¿ ROOT CAUSE DESCRIPTION. ALL MATERIALS PASSED IN-PROCESS AND FINAL ACCEPTANCE CRITERIA AND PROCESS IS UNDER INVESTIGATION. ¿ CAPA# : NA. ¿ CAPA RATIONALE: THE COMPLAINT SEVERITY WAS LOW (S1). BASED ON THE EVALUATION OF COMPLAINT SEVERITY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE COMPLAINT WAS REVIEWED, AND NO ADVERSE EVENT HAS OCCURRED AT THIS TIME. NO NON-CONFORMANCE HAS OCCURRED. THIS COMPLAINT MODE WILL BE TRENDED, AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS REACHED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WITH PATIENT SAMPLES WITH A BD ONEFLOW¿ ALOT. THERE WAS NO DELAY IN TREATMENT, AND SAMPLES WERE NOT RE-DRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MPO FITC SPILLOVER INTO PE CHANNEL AND CD7 APC SPILLOVER INTO SCD3 APC-H7 IS NOT CORRECTLY COMPENSATED WHEN ACQUIRING DATA ON ONEFLOW A LOT TUBES AND ONEFLOW SETTINGS. BETWEEN, USER IS USING BD INTRASURE KIT FOR THE INTRACELLULAR STAINING. ADDITIONALLY, ON 2020-07-10 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿ WAS THE PROBLEM OBSERVED ON A PATIENT SAMPLE INTENDED FOR CLINICAL USE? THE PROBLEM OBSERVED ON PATIENT SAMPLES. ¿ IF SO WAS THERE ANY IMPACT TO THE PATIENT? NO. THE USERS RUN BOTH AML PANEL AND T-ALL TO COUNTER CHECK THE RESULT OF ALOT SCREENING TUBE. ¿ WERE SAMPLES REDRAWN? NO. ¿ WAS THERE ANY DELAY IN TREATMENT? NO.