BD FACSCANTO¿ II FLOW CYTOMETER

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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. PLOT NOT CORRECT

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE 'PLOT NOT CORRECT' WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DHR WAS REVIEWED AND THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE, ALSO PERFORMED REVIEW OF COMPLAINT TREND, DEFECT TREND, RISK ANALYSIS, AND SERVICE REPORT. BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE OF INCORRECT PLOT WAS CLEANING ISSUE WITH FLOWCELL. 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 FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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 PLOT NOT CORRECT.