BD FACSLYRIC¿

Additional Manufacturer Narrative

D4: MEDICAL DEVICE EXPIRATION DATE: NA. H3: 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 OBTAINED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS STILL OPEN, THE CUSTOMER WANTED TO COME BACK TO US, WHEN IT APPEARS AGAIN. IT SEEMS THAT THIS DIDN´T HAPPEN IN THE MEANTIME. THE CUSTOMER HIMSELF MENTIONED THAT HE DOESN´T EXPECT THAT IT IS CARRYOVER. FOR ME IT SOUNDS LIKE AN EFFECT FROM DOUBLETTES AND IT´S JUST A MATTER OF SUSPENSION, BUT WE CANNOT SAY MORE WITHOUT GETTING THESE MEASUREMENTS FROM CUSTOMER¿S SIDE. SORRY, BUT I CANNOT TELL YOU MORE ABOUT NOW. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MEASUREMENTS WITH MIRROR POPULATIONS ARE NOT USED, THE MEASUREMENTS ARE REPEATED, THEREFORE NO WRONG RESULTS THE CUSTOMER SENDS MEASUREMENT RESULTS WHEN IT OCCURS AGAIN, AS WELL AS THE SHR AND THE TIME WHEN THE EFFECT OCCURRED. OCCASIONALLY, MIRROR POPULATIONS OCCUR DURING THE MEASUREMENTS, WHICH ARE SLIGHTLY TO THE RIGHT, ARE SHARPLY SEPARATED AND THEN DISAPPEAR COMPLETELY AGAIN AFTER CLEANING. CARRY OVER CAN BE RULED OUT SINCE IT ALSO OCCURS WHEN MEASURING THE SAME SAMPLE.

Additional Manufacturer Narrative

H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE REGARDING MIRROR POPULATIONS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE MIRROR POPULATIONS COULD NOT BE DETERMINED. AFTER THE COMPLAINT WAS REPORTED, THE INSTRUMENT UNDERWENT SERVICE AND MAINTENANCE. AFTER THE SERVICING, THE PROBLEM DID NOT REOCCUR. THE INSTRUMENT WAS IN REGULAR USE AFTER SERVICING AND NO FURTHER PROBLEMS WERE NOTED. THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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 OBTAINED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS STILL OPEN, THE CUSTOMER WANTED TO COME BACK TO US, WHEN IT APPEARS AGAIN. IT SEEMS THAT THIS DIDN´T HAPPEN IN THE MEANTIME. THE CUSTOMER HIMSELF MENTIONED THAT HE DOESN´T EXPECT THAT IT IS CARRYOVER. FOR ME IT SOUNDS LIKE AN EFFECT FROM DOUBLETTES AND IT´S JUST A MATTER OF SUSPENSION, BUT WE CANNOT SAY MORE WITHOUT GETTING THESE MEASUREMENTS FROM CUSTOMER¿S SIDE. SORRY, BUT I CANNOT TELL YOU MORE ABOUT NOW. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MEASUREMENTS WITH MIRROR POPULATIONS ARE NOT USED, THE MEASUREMENTS ARE REPEATED, THEREFORE NO WRONG RESULTS. THE CUSTOMER SENDS MEASUREMENT RESULTS WHEN IT OCCURS AGAIN, AS WELL AS THE SHR AND THE TIME WHEN THE EFFECT OCCURRED. OCCASIONALLY, MIRROR POPULATIONS OCCUR DURING THE MEASUREMENTS, WHICH ARE SLIGHTLY TO THE RIGHT, ARE SHARPLY SEPARATED AND THEN DISAPPEAR COMPLETELY AGAIN AFTER CLEANING. CARRY OVER CAN BE RULED OUT SINCE IT ALSO OCCURS WHEN MEASURING THE SAME SAMPLE

Additional Manufacturer Narrative

THE FOLLOW FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131. G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.6 IMDRF ANNEX F CODE: F26. H.6 IMDRF ANNEX B CODES: B14, B12, B11 AND B17. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE REGARDING MIRROR POPULATIONS COULD NOT BE CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE MIRROR POPULATIONS COULD NOT BE DETERMINED. AFTER THE COMPLAINT WAS REPORTED, THE INSTRUMENT UNDERWENT SERVICE AND MAINTENANCE. AFTER THE SERVICING, THE PROBLEM DID NOT REOCCUR. THE INSTRUMENT WAS IN REGULAR USE AFTER SERVICING AND NO FURTHER PROBLEMS WERE NOTED. THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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 OBTAINED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS STILL OPEN, THE CUSTOMER WANTED TO COME BACK TO US, WHEN IT APPEARS AGAIN. IT SEEMS THAT THIS DIDN´T HAPPEN IN THE MEANTIME. THE CUSTOMER HIMSELF MENTIONED THAT HE DOESN´T EXPECT THAT IT IS CARRYOVER. FOR ME IT SOUNDS LIKE AN EFFECT FROM DOUBLETTES AND IT´S JUST A MATTER OF SUSPENSION, BUT WE CANNOT SAY MORE WITHOUT GETTING THESE MEASUREMENTS FROM CUSTOMER¿S SIDE. SORRY, BUT I CANNOT TELL YOU MORE ABOUT NOW. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS MEASUREMENTS WITH MIRROR POPULATIONS ARE NOT USED, THE MEASUREMENTS ARE REPEATED, THEREFORE NO WRONG RESULTS THE CUSTOMER SENDS MEASUREMENT RESULTS WHEN IT OCCURS AGAIN, AS WELL AS THE SHR AND THE TIME WHEN THE EFFECT OCCURRED. OCCASIONALLY, MIRROR POPULATIONS OCCUR DURING THE MEASUREMENTS, WHICH ARE SLIGHTLY TO THE RIGHT, ARE SHARPLY SEPARATED AND THEN DISAPPEAR COMPLETELY AGAIN AFTER CLEANING. CARRY OVER CAN BE RULED OUT SINCE IT ALSO OCCURS WHEN MEASURING THE SAME SAMPLE.