BD TRUCOUNT¿ TUBES

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.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO. 2. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES. 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO. LEUCOCYTE COUNTS WITH LOT 3186043 ARE TOO HIGH AND DEVIATE FROM HEMATO ANALYZER WITH 25% WHEN DID THE INCIDENT OCCUR? DURING USE DETAILED INCIDENT DESCRIPTION LEUCOCYTE COUNTS WITH LOT 3186043 ARE HIGHER COMPARED TO COUNTS FROM SAME SAMPLE WITH HEMATO ANALYZER. DEVIATION WITH 25% FOR BOTH PATIENT SAMPLES AND CONTROL MATERIAL. WITH MULTIPLE PREPARATIONS, BY MULTIPLE TECHNICIANS.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR. H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE, TRUCOUNT TUBES LOT 23128, THAT PRODUCED LEUCOCYTE COUNTS TOO HIGH COMPARED TO COUNTS FROM SAME SAMPLE USING A HEMATO ANALYZER (25% DEVIATION) RESULTING IN ERRONEOUS RESULTS WAS NOT CONFIRMED AS PRODUCT IS PERFORMING AS INTENDED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: RETAIN SAMPLE TESTING THAT SHOWED THAT THE PRODUCT WAS PERFORMING AS INTENDED. BATCH HISTORY RECORD (BHR) REVIEW SHOWING THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH ESTABLISHED PROCESSES AND PROCEDURES. THE POTENTIAL CAUSE OF THE VARIABILITY IN THE RESULTS OBSERVED BY THE CUSTOMER USING DIFFERENT TECHNOLOGIES IS NOT DETERMINED. 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 ON PATIENT SAMPLES DURING USE WITH THE BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO. 2. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES. 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO. LEUCOCYTE COUNTS WITH LOT 3186043 ARE TOO HIGH AND DEVIATE FROM HEMATO ANALYZER WITH 25% WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION. LEUCOCYTE COUNTS WITH LOT 3186043 ARE HIGHER COMPARED TO COUNTS FROM SAME SAMPLE WITH HEMATO ANALYZER. DEVIATION WITH 25% FOR BOTH PATIENT SAMPLES AND CONTROL MATERIAL. WITH MULTIPLE PREPARATIONS, BY MULTIPLE TECHNICIANS.