BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CD11B (D12) APC

    MDR report key: 17549553 · Received August 15, 2023

    Report

    Report Number
    2916837-2023-00168
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 20, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H3. INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: MANUFACTURING DEFECT TREND: THERE ARE ZERO (0) QUALITY NOTIFICATIONS (QN) OR NONCONFORMANCE REPORTS AGAINST PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710 OR SUBASSEMBLY 91-0415 (CD11B APC) BATCH 3095009, FROM EVALUATED DATE RANGE FROM (B)(6) 2022 TO (B)(6) 2023. BATCH HISTORY RECORD (BHR) REVIEW: PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710 WAS ASSEMBLED IN BDB CAYEY (PLANT 1157) USING SUBASSEMBLY 91-0415 (CD11B APC) BATCH 3095009. QC BHR 91-0415 (CD11B APC) BATCH 3095009 WAS REVIEWED. MATERIAL MET SPECIFICATIONS PRIOR RELEASE: FLUOROMETRY TEST VS REFERENCE (SPECIFICATION -40% TO +80% OF REFERENCE) RESULT OF -22%, AND AGFC PERCENT FREE FLUOROPHORE (SPECIFICATION =20% OF FREE APC CONJUGATE DYE) RESULT OF 8.8%, PRIOR TO RELEASE. MATERIAL EXPIRES 28-FEB-25. NO DISCREPANCY IDENTIFIED ON EVALUATED QC RECORDS AND DATA. FORMULATION MANUFACTURING BHR OF MATERIAL 91-0415 (CD11B APC) BATCH 3095009 AND CONJUGATION BULK MATERIAL 50-00236 (CD11B APC) BATCH 3080848 BHR WERE EVALUATED. NO DISCREPANCY OR DEVIATION IDENTIFIED ON EVALUATED FORMULATION BHR FOR0004-PR (REV. 20), WHICH DEMONSTRATE MATERIAL 91-0415 (CD11B APC) BATCH 3095009 WAS FORMULATED AT APPLICABLE BOTTLING CONCENTRATION (0.05 MG/ML) AND FOLLOWING MANUFACTURING SPECIFICATION INSTRUCTIONS 91-0415MS-PR (REV.2). NO DISCREPANCY OR DEVIATION IDENTIFIED ON EVALUATED CONJUGATION BHR OF BULK MATERIAL 50-00236 (CD11B APC) BATCH 3080848. ASSESSMENT OF BHR IN-PROCESS DATA OF BULK CD11B APC FRACTIONS POOLED SHOW CHARACTERISTICS OF HIGHER FREE (PURE) CD11B IGG AB CONTENT THAN CD11B APC CONJUGATE ON BATCH 3080848, NOT ALIGNED WITH APC TO ANTIBODY CONCENTRATION AND APC SIZING REQUIREMENTS, WHICH EXPLAINS THE LOW (NEARLY NEGATIVE) SIGNAL ON AFFECTED CD11B APC PRODUCTS MANUFACTURED USING SUBASSEMBLY MATERIAL 91-0415 (CD11B APC) BATCH 3095009. COMPLAINT HISTORY REVIEW: EIGHTEEN (18) COMPLAINT REPORTS AGAINST PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710 FROM (B)(6) 2022 TO (B)(6) 2023 RELATED TO POOR/DIM OR NO SIGNAL MARK PERFORMANCE. AFFECTED PRODUCTS WERE MANUFACTURED USING SAME SUBASSEMBLY MATERIAL 91-0415 (CD11B APC) BATCH 3095009. RETAIN SAMPLE ANALYSIS: FLOW CYTOMETRY TESTING WAS PERFORMED ON RETAIN SAMPLES OF 91-0415 (CD11B APC) BATCH 3095009 AND BULK MATERIAL 50-00236 (CD11B APC) BATCH 3080848, WHICH CONFIRM POOR SIGNAL CLAIMS IS ATTRIBUTED TO AFFECTED BULK MATERIAL BATCH 3080848 AS THE PROBLEM SOURCE. INVESTIGATION ESCALATED TO CAPA PR# 8466530. RETURNED SAMPLE ANALYSIS: THE CUSTOMERS SAMPLE/DATA WAS NOT REQUESTED BECAUSE RETAIN SAMPLE WAS TESTED AND REPORTED PERFORMANCE PROBLEM WAS CONFIRMED. POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE CAUSE IS ATTRIBUTED TO INCORRECT CD11B APC ANTIBODY FRACTION POOLING DURING CONJUGATION OF BULK MATERIAL 50-00236 (CD11B APC) BATCH 3080848 USED TO FORMULATE SUBASSEMBLY 91-0415 (CD11B APC) BATCH 3095009 USED FOR PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, BHR REVIEW, RISK ANALYSIS, CUSTOMER PROVIDED DATA AND RETAIN SAMPLE ANALYSIS, THE COMPLAINT OF PERFORMANCE PROBLEM REPORTED AGAINST PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710 WAS CONFIRMED. CONCLUSION: BASED ON INVESTIGATION FINDINGS AND RESULTS FOR PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710, COMPLAINT IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED DURING USE WITH THE BD CD11B (D12) APC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT DOES NOT MARK CORRECTLY. IT DOES NOT MARK CORRECTLY AND WHAT SHOULD BE POSITIVE COMES OUT NEGATIVE. IT HAS BEEN REPEATED 3 TIMES WERE ANY ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? - NO, THEY WERE MADE AWARE OF IT BEFORE GIVING THE RESULT WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? - NO, WHEN THEY SAW THE RESULT THEY DID NOT TRUST IT AND REPEATED IT WITH ANOTHER VIAL. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? - NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED DURING USE WITH THE BD CD11B (D12) APC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT DOES NOT MARK CORRECTLY. IT DOES NOT MARK CORRECTLY AND WHAT SHOULD BE POSITIVE COMES OUT NEGATIVE. IT HAS BEEN REPEATED 3 TIMES WERE ANY ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? - NO, THEY WERE MADE AWARE OF IT BEFORE GIVING THE RESULT. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? - NO, WHEN THEY SAW THE RESULT THEY DID NOT TRUST IT AND REPEATED IT WITH ANOTHER VIAL. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? - NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994518 BD CD11B (D12) APC FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 3114710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown