BD FACSDUET SAMPLE PREP

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: PER THE FSE: PROBLEM VERIFICATION, FLUIDIC COMPONENT CHECK FOR LEAKS, FROM CUSTOMER'S 12 MONTH PM KIT # 663925 REPLACEMENT SPECIMEN PROBE (# 62000349 / LOT ASO165 / ID10075138), SYRINGE # 663249 AND DISPENSING VALVE # 663247. REFERENCE POINT CHECK, SAMPLE DISPENSING PROBE TEACHING EXECUTION. CONTROL OF GOOD FUNCTIONING WITH CUSTOMER SAMPLES. THE MUKTICHECK CHECK IS NOW PASSED SUCCESSFULLY. REGULARLY FUNCTIONING APPLIANCE. THE PROBLEM DID NOT AFFECT ROUTINE AND RESULT GENERATION AS THE SAMPLES WERE NOT ANALYZED UNTIL THE PROBLEM WAS RESOLVED. REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN: 662588 (NON COOLED) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE SYSTEM NEEDED MAINTENANCE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS "LOW" ABSOLUTE COUNTS. A CONFIRMATORY ANALYSIS WAS CONDUCTED WITH THE SAME RESULTS. THERE IS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CUSTOMER REPORTS THAT THE ABSOLUTE COUNTS OBTAINED FROM THE CD45 \ CD3 \ CD4 \ CD8 ASSAY OF YESTERDAY'S SAMPLES ARE VERY LOW WHEN COMPARED TO THE EXPECTATIONS. THE VALUES ARE ALMOST HALF OF THE EXPECTATIONS. THE PERCENTAGES, ON THE OTHER HAND, ARE IN LINE WITH EXPECTATIONS. THE SAME PROBLEM WAS FOUND ON THE MULTICHECK SAMPLE LOT BM0920L. THE CLIENT REPEATED THE ANALYSIS THIS MORNING BUT GOT THE SAME RESULTS. THE CUSTOMER SUSPECTS THERE MAY BE A SAMPLE DISPENSING PROBLEM IN TRUCOUNT TUBES.

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS "LOW" ABSOLUTE COUNTS. A CONFIRMATORY ANALYSIS WAS CONDUCTED WITH THE SAME RESULTS. THERE IS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER REPORTS THAT THE ABSOLUTE COUNTS OBTAINED FROM THE CD45 \ CD3 \ CD4 \ CD8 ASSAY OF YESTERDAY'S SAMPLES ARE VERY LOW WHEN COMPARED TO THE EXPECTATIONS. THE VALUES ARE ALMOST HALF OF THE EXPECTATIONS. THE PERCENTAGES, ON THE OTHER HAND, ARE IN LINE WITH EXPECTATIONS. THE SAME PROBLEM WAS FOUND ON THE MULTICHECK SAMPLE LOT BM0920L. THE CLIENT REPEATED THE ANALYSIS THIS MORNING BUT GOT THE SAME RESULTS. THE CUSTOMER SUSPECTS THERE MAY BE A SAMPLE DISPENSING PROBLEM IN TRUCOUNT TUBES.