BD TRUCOUNT¿ TUBES

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 5020331. D.4. MEDICAL DEVICE EXPIRATION DATE: 31OCT2026. H.4. DEVICE MANUFACTURE DATE: 20JAN2025. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION D.4. UNIQUE IDENTIFIER (UDI) # (B)(4). G.1 MANUFACTURING LOCATION: BD CARIBE, LTD - CAYEY PR / 00737. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE ¿TRUCOUNT ABSOLUTE COUNTING TUBES SHOWING VARIABILITY BETWEEN TUBES¿ WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: CUSTOMER PROVIDED DATA, REVIEW OF COMPLAINT TREND, DEFECT TREND, BATCH HISTORY REVIEW AND RISK ANALYSIS. RETAIN SAMPLE TESTING WAS PERFORMED, AND SATISFACTORY TEST RESULTS WERE OBTAINED. THE RETAIN SAMPLE MATERIAL 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 24328 WAS TESTED FOR ABSOLUTE BEAD COUNT ON 11-JUN-2025 AND EVALUATED. THE RESULT WAS 45,850 BEADS PER PELLET, OR -0.4% FROM ASSIGNED BEAD COUNT, WHICH IS WITHIN THE 10% ASSIGNED 47,050 BEADS PER PELLET COUNT FOR THE MATERIAL 91-0195 (TRUCOUNT ABSOLUTE COUNT PELLET) BATCH 4191214. CUSTOMER DATA WAS EVALUATED, GUIDANCE ON BD TRUCOUNT ABSOLUTE COUNTING TUBES PRODUCT USE IS PROVIDED ON (IFU) 23-22402, REV 03. INCLUDING PRECAUTIONS, SPECIMEN COLLECTION AND PREPARATION, PROCEDURE FOR STAINING AND PIPETTING. THE POTENTIAL CAUSE FOR THIS ISSUE WAS NOT DETERMINED. THE ISSUE WAS RESOLVED BY PROVIDING A REPLACEMENT LOT TO THE CUSTOMER.

Additional Manufacturer Narrative

G.5. ADDITIONAL PMA / 510(K)#: K090967, K980858, K971205, K971110, K970326,K970742, K071143 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 WHILE USING BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBSERVED AND REPORTED TO A CLINICIAN. THE NUMBER OF PATIENTS AFFECTED COULD NOT BE CONFIRMED AND NO SERIOUS INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CD45 ABSOLUTE COUNT FOR THE 3 TUBES FOR THE PIP DOES NOT MATCH THUS THE ABSOLUTE COUNTS FOR THE LYMPHOCYTE MARKERS ARE INACCURATE. IT AFFECTED MANY RESULTS THAT WE HAVE TO REPEAT AND POSSIBLE OTHER RESULTS THAT WE HAVE ALREADY REPORTED THAT WE CAN NO LONGER REPEAT DUE TO SAMPLE STABILITY. WE DON'T KNOW IF THERE ARE SINGLE-TUBE ASSAY THAT WE REPORTED INCORRECTLY, LIKE I MENTIONED EARLIER IT WOULD BE HARD TO CATCH IT IN A SINGLE-TUBE ASSAY AND WE HAVE NOT RECEIVED ANY CALLS FROM OUR CLIENTS, YET. SO, WE DON'T KNOW THE ANSWER TO THE FOLLOWING QUESTIONS.