BD CD11B (D12) APC

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD CD11B (D12) APC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON USE, THEY DISCOVERED LOWER MFI COMPARED TO OLDER BATCHES. BEFORE USE. ¿ WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES, WHEN ANALYZING THE PATIENT SAMPLE THE CUSTOMER OBSERVED VERY WEAK SIGNAL FROM THE ANTIBODY AND STOPPED THE PROCESS. ¿ WHETHER CARRY OVER HAPPENED ON PATIENT SAMPLES? I¿M NOT SURE WHAT YOU MEAN BY CARRY OVER IN THIS CASE ? ¿ COULD YOU PLEASE PROVIDE INFORMATION WHETHER THE PATIENT IS IMPACTED OR NOT? PATIENTS ARE NOT IMPACTED.

Additional Manufacturer Narrative

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: G.1. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES G.2. REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR G.4. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR H.6. IMDRF ANNEX F GRID: F26 H.6. INVESTIGATION SUMAMRY BASED ON THE INVESTIGATION RESULTS, THE REPORTED PERFORMANCE ISSUE FOR PRODUCT 333143, LOT 3114710 IS CONFIRMED TO BE RELATED TO THE MANUFACTURING PROCESS. BD ACKNOWLEDGES THE CUSTOMER¿S EXPERIENCE REGARDING THE INDICATED FAILURE MODE OF LOWER MEAN FLUORESCENCE INTENSITY (MFI) COMPARED TO OLDER BATCHES WHILE USING PRODUCT 333143 (CD11B APC, CLONE D12, CE-IVD) LOT 3114710. BD HAS CONDUCTED FURTHER INVESTIGATION RELATING TO THIS ISSUE WHICH WAS CONFIRMED AND HAS IDENTIFIED POTENTIAL CAUSE RELATED TO THE CD11B APC CONJUGATE MANUFACTURING. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND IMPLEMENTED. 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 ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD CD11B (D12) APC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON USE, THEY DISCOVERED LOWER MFI COMPARED TO OLDER BATCHES. BEFORE USE. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES, WHEN ANALYZING THE PATIENT SAMPLE THE CUSTOMER OBSERVED VERY WEAK SIGNAL FROM THE ANTIBODY AND STOPPED THE PROCESS. WHETHER CARRY OVER HAPPENED ON PATIENT SAMPLES? I¿M NOT SURE WHAT YOU MEAN BY CARRY OVER IN THIS CASE ? COULD YOU PLEASE PROVIDE INFORMATION WHETHER THE PATIENT IS IMPACTED OR NOT? PATIENTS ARE NOT IMPACTED.