BD FACS¿ LYSE WASH ASSISTANT

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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CONTAMINATED LINES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GETTING HIGH BACKGROUND ON ALL OF MY LEUKEMIA AND LYMPHOMA PANELS. I HAVE ISOLATED IT TO SOMETHING ON THE LWA. THE ISSUE ONLY HAPPENS WHEN I RUN ON THE LWA. IF I DO A MANUAL PROCEDURE EVERYTHING WORKS FINE. PATIENT SAMPLES CONTAMINATED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CONTAMINATED LINES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GETTING HIGH BACKGROUND ON ALL OF MY LEUKEMIA AND LYMPHOMA PANELS. I HAVE ISOLATED IT TO SOMETHING ON THE LWA. THE ISSUE ONLY HAPPENS WHEN I RUN ON THE LWA. IF I DO A MANUAL PROCEDURE EVERYTHING WORKS FINE. PATIENT SAMPLES CONTAMINATED

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: H.6 ANNEX G CODE: G04069 H.6 INVESTIGATION SUMMARY: INVESTIGATION EXECUTIVE SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING HIGH BACKGROUND ON LYMPHOMA PANELS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: -THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. -REVIEW OF THE DEVICE HISTORY RECORD (DHR). -CONDUCTED SYSTEM CALIBRATION AND TESTING THE POTENTIAL CAUSE OF HIGH BACKGROUND ON LYMPHOMA PANELS WAS DUE TO CLOGGED AND DIRTY FLUIDIC LINES WHERE TUBING AND CONNECTORS NEEDED TO BE REPLACED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.