BD FACSLYRIC¿

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(6). G.1 - REPORTING OFFICE CONTACT - (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.3. BASED ON THE INVESTIGATION RESULTS WHICH INCLUDES DHR REVIEW, THE REPORTED ISSUE FOR THE ABNORMAL ACQUISITION SPEED AND FAILING BLUE LASER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE FOR THE ABNORMAL ACQUISITION SPEED AND FAILING BLUE LASER WAS RELATED TO THE OPTICAL GEL. 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 OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE) 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IT WAS REPORTED BY THE CUSTOMER THAT ACQUISITION TOO FAST (1.7X). TALKED WITH CX. CX SAYS THIS LYRIC IS ASPIRATING SAMPLE MORE VOLUMETRICALLY THAN THE OTHER LYRIC IN THE LAB. THE ISSUE IS MOST NOTABLE USING 96 WELL PLATES AND NOT WITH SAMPLE TUBES. CX GUESSED THE INCREASED VOLUMETRIC RATE IS 1.7 TIMES FASTER THAN THE OTHER LYRIC. PQC PASSES WITHOUT ISSUE. THE EVENT RATE DOESN'T SEEM TO BE INCREASED BUT THEY SEEM TO RUN OUT OF SAMPLE WHEN ASPIRATING/ COLLECTING USING A 96 WELL PLATE. I ASKED IF THEY COMPARED THE 96 WELL PLATES AFTER ACQUISITION BETWEEN THIS INSTRUMENT AND THE OTHER LYRIC TO SEE IF MAYBE THIS LYRIC'S STINGER MAY BE SET HIGHER NOT GOING ALL THE WAY INTO THE WELL BOTTOM THUS RUNNING OUT OF SAMPLE THINKING IT IS CONSUMING MORE SAMPLE. I ALSO ASKED WHEN THE LAST TIME A MONTHLY CLEAN WAS PERFORMED. CX SAYS THE INSTRUMENT IS COMING UP FOR THE MONTHLY CLEAN, THEY USE 10% BLEACH FOR THE PROCEDURE. CX REQUESTED A DISPATCH BUT WILL TRY A MONTHLY CLEAN IN THE MEAN TIME TO SEE IF IT REDUCES THE SAMPLE VOLUME CONSUMPTION ISSUE. SHE WOULD LIKE TO GET THE ISSUE RESOLVED AS THEY ARE SPENDING MORE TIME RE-RUNNING PATIENT SAMPLES ON THIS INSTRUMENT.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. G.5. PMA / 510(K)#: BK230835, K170974, K201814. 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 DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE). 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IT WAS REPORTED BY THE CUSTOMER THAT ACQUISITION TOO FAST (1.7X). TALKED WITH CX. CX SAYS THIS LYRIC IS ASPIRATING SAMPLE MORE VOLUMETRICALLY THAN THE OTHER LYRIC IN THE LAB. THE ISSUE IS MOST NOTABLE USING 96 WELL PLATES AND NOT WITH SAMPLE TUBES. CX GUESSED THE INCREASED VOLUMETRIC RATE IS 1.7 TIMES FASTER THAN THE OTHER LYRIC. PQC PASSES WITHOUT ISSUE. THE EVENT RATE DOESN'T SEEM TO BE INCREASED BUT THEY SEEM TO RUN OUT OF SAMPLE WHEN ASPIRATING/ COLLECTING USING A 96 WELL PLATE. I ASKED IF THEY COMPARED THE 96 WELL PLATES AFTER ACQUISITION BETWEEN THIS INSTRUMENT AND THE OTHER LYRIC TO SEE IF MAYBE THIS LYRIC'S STINGER MAY BE SET HIGHER NOT GOING ALL THE WAY INTO THE WELL BOTTOM THUS RUNNING OUT OF SAMPLE THINKING IT IS CONSUMING MORE SAMPLE. I ALSO ASKED WHEN THE LAST TIME A MONTHLY CLEAN WAS PERFORMED. CX SAYS THE INSTRUMENT IS COMING UP FOR THE MONTHLY CLEAN, THEY USE 10% BLEACH FOR THE PROCEDURE. CX REQUESTED A DISPATCH BUT WILL TRY A MONTHLY CLEAN IN THE MEAN TIME TO SEE IF IT REDUCES THE SAMPLE VOLUME CONSUMPTION ISSUE. SHE WOULD LIKE TO GET THE ISSUE RESOLVED AS THEY ARE SPENDING MORE TIME RE-RUNNING PATIENT SAMPLES ON THIS INSTRUMENT.