FACSCANTO¿ 10-COLOR CONFIGURATION

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH FACSCANTO¿ 10-COLOR CONFIGURATION CARRY OVER OCCURRED. THE ISSUE WAS DISCOVERED IN THE LAB AND ERRONEOUS RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX (FLOW CYTOMETRY MANAGER) REPORTED A SPINAL FLUID SAMPLE THEY RAN BECAME CONTAMINATED. THE SYSTEM OPERATOR DID NOT USE THE "REMOVE TUBE" COMMAND AND POSSIBLE DID NOT FULLY SWING THE ASPIRATOR TO THE LEFT TO INITIATE A SIP CLEANING CYCLE AFTER REMOVING THE PRECEDING SAMPLE. THE SYSTEM DID NOT SUFFICIENTLY CLEAN THE SYSTEM SAMPLE PROBE BEFORE RUNNING THE SPINAL FLUID. THE LAB HAS IMPLEMENTED ADDITIONAL STAFF TRAINING TO PREVENT A RE-OCCURRENCE. THE SPINAL FLUID SAMPLE APPEARED TO INDICATE A POSITIVE LEUKEMIA. INTERNAL LAB PROCEDURES AND CROSS CHECKING CAUGHT THE ISSUE BEFORE RESULTS WERE REPORTED. MDR SAFETY CHECKLIST -- CONTAMINATION: 1. WERE SAMPLES CONTAMINATED? YES. 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? UNKNOWN. 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. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUSTION #6): THE ISSUE WAS FOUND IN THE LAB BEFORE THE RESULTS WERE REPORTED. 6.WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTION REQUIRED.): UNKNOWN BUT NO ERRONEOUS RESULT WAS REPORTED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS, THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF CARRYOVER WAS DETERMINED TO BE CUSTOMER USAGE PROBLEM. TO RESOLVE THE ISSUE THE CUSTOMER IMPLEMENTED ADDITIONAL STAFF TRAINING. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. NO ONE WAS HARMED OR INJURED FROM THESE ERRONEOUS RESULTS. THE INSTRUMENT IS FUNCTIONING AS EXPECTED. 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 DURING USE WITH FACSCANTO¿ 10-COLOR CONFIGURATION CARRY OVER OCCURRED. THE ISSUE WAS DISCOVERED IN THE LAB AND ERRONEOUS RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX (FLOW CYTOMETRY MANAGER) REPORTED A SPINAL FLUID SAMPLE THEY RAN BECAME CONTAMINATED. THE SYSTEM OPERATOR DID NOT USE THE "REMOVE TUBE" COMMAND AND POSSIBLE DID NOT FULLY SWING THE ASPIRATOR TO THE LEFT TO INITIATE A SIP CLEANING CYCLE AFTER REMOVING THE PRECEDING SAMPLE. THE SYSTEM DID NOT SUFFICIENTLY CLEAN THE SYSTEM SAMPLE PROBE BEFORE RUNNING THE SPINAL FLUID. THE LAB HAS IMPLEMENTED ADDITIONAL STAFF TRAINING TO PREVENT A RE-OCCURRENCE. THE SPINAL FLUID SAMPLE APPEARED TO INDICATE A POSITIVE LEUKEMIA. INTERNAL LAB PROCEDURES AND CROSS CHECKING CAUGHT THE ISSUE BEFORE RESULTS WERE REPORTED. MDR SAFETY CHECKLIST -- CONTAMINATION 1. WERE SAMPLES CONTAMINATED? YES 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? UNKNOWN 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 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUSTION #6): THE ISSUE WAS FOUND IN THE LAB BEFORE THE RESULTS WERE REPORTED 6.WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTION REQUIRED.): UNKNOWN BUT NO ERRONEOUS RESULT WAS REPORTED.

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.