BD FACS¿ LYSE WASH ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT. CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED BY THE CUSTOMER: SAMPLE CARRY-OVER"

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: IMDRF ANNEX A GRID: A1801. H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER 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. REVIEW OF THE DEVICE HISTORY RECORD (DHR). THE POTENTIAL CAUSE COULD NOT BE DETERMINED BECAUSE THE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE ISSUE. THE FSE PERFORMED PREVENTIVE MAINTENANCE AND VERIFIED THAT THERE WAS NO CARRYOVER. 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 WHILE USING BD FACS¿ LYSE WASH ASSISTANT. CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED BY THE CUSTOMER: SAMPLE CARRY-OVER."

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.