BD FACSLYRIC¿

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE CD4 FALLING OUT OF RANGE AND CARRYOVER 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 CUSTOMER EXPERIENCING CD4 FALLING OUT OF RANGE AND CARRYOVER, WAS WORN FLUIDICS PARTS ON THE INSTRUMENT. THE ISSUE WAS RESOLVED AFTER THE PARTS WERE REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE OF THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CD4 NOT FALLING WITHIN RANGE ON SEVERAL OCCASIONS FOR MULTITEST NORM CONTROL (349701). CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. CARRY OVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SMALL AMOUNT OF CARRYOVER BETWEEN SAMPLES. IS THERE A SPECIFIC REASON FOR CHECKING THE ASSAY MULTIPLE TIMES? IS IT FAILING THE FIRST TIME AND IT IS BEING RECHECKED? OUR PROCESS IS TO RUN MULTICHECK CONTROLS (NORMAL AND LOW) FOR BOTH ASSAYS (3/8/45/4 AND TBNK) ON BOTH LYRICS. FROM TIME TO TIME, ONE OF THEM WILL FAIL ON ONE LYRIC BUT PASS ON THE OTHER, WHICH SPEAKS TO THE POINT THAT IT¿S NOT THE TUBE, BUT THE INSTRUMENT RUN. SO THEN WE RE-RUN THE FAILED QC ON THE FIRST LYRIC AND IT COMES ¿IN¿ ON THE RE-RUN. WHEN THERE IS A FAILURE, IS THE TUBE VORTEXED BEFORE BEING RUN? DOES THE TUBE PASS WHEN THE TUBES ARE VORTEXED? IT IS VORTEXED BEFORE THE RUN AND BEFORE THE RE-RUN. CAN WE HAVE THE LOT NUMBERS OF THE MULTICHECK VIALS, THEIR LOT NUMBERS AND IF THE VIALS LOOK HEMOLYZED? FOR THE EXAMPLES THAT I SHOWED, JUNE WAS: NORMAL BM0624N LOW BM0624L AND SEPT WAS: NORMAL BM0924N LOW BM0924L. THEY WERE NOT HEMOLYZED.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED DURING USE OF THE BD FACSLYRIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CD4 NOT FALLING WITHIN RANGE ON SEVERAL OCCASIONS FOR MULTITEST NORM CONTROL (349701). CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. CARRY OVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SMALL AMOUNT OF CARRYOVER BETWEEN SAMPLES. IS THERE A SPECIFIC REASON FOR CHECKING THE ASSAY MULTIPLE TIMES? IS IT FAILING THE FIRST TIME AND IT IS BEING RECHECKED? OUR PROCESS IS TO RUN MULTICHECK CONTROLS (NORMAL AND LOW) FOR BOTH ASSAYS (3/8/45/4 AND TBNK) ON BOTH LYRICS. FROM TIME TO TIME, ONE OF THEM WILL FAIL ON ONE LYRIC BUT PASS ON THE OTHER, WHICH SPEAKS TO THE POINT THAT IT¿S NOT THE TUBE, BUT THE INSTRUMENT RUN. SO, THEN WE RE-RUN THE FAILED QC ON THE FIRST LYRIC AND IT COMES ¿IN¿ ON THE RE-RUN. WHEN THERE IS A FAILURE, IS THE TUBE VORTEXED BEFORE BEING RUN? DOES THE TUBE PASS WHEN THE TUBES ARE VORTEXED? IT IS VORTEXED BEFORE THE RUN AND BEFORE THE RE-RUN. CAN WE HAVE THE LOT NUMBERS OF THE MULTICHECK VIALS, THEIR LOT NUMBERS AND IF THE VIALS LOOK HEMOLYZED? FOR THE EXAMPLES THAT I SHOWED, JUNE WAS: NORMAL BM0624N LOW BM0624L AND SEPT WAS: NORMAL BM0924N LOW BM0924L. THEY WERE NOT HEMOLYZED.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.