BD FACSCANTO¿ II

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. E.7. INITIA REPORTER ADDRESS: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II ERRONEOUS RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT NOR ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CYTOMETER IS GIVING RARE POPULATIONS AND REQUIRES LACK OF SCALING AREA ADJUSTMENT. "1. WERE THERE ERRONEOUS RESULTS IN PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES, THE POPULATION WAS IDENTIFIED, BUT THE RESULT WAS NOT RELEASED TO THE PATIENT. 2. WAS THERE ANY DELAY IN TREATMENT DUE TO THE PROBLEM? THE SAMPLE WAS ORDERED TO BE SUBROGATED. 3. IF PATIENTS WERE RE-SAMPLED, WERE THERE ANY CHANGES OR DELAYS IN TREATMENT? THE SAMPLES WERE SUBROGATED AND THE APPROPRIATE RESULT WAS RELEASED, THERE WAS NO WRONG TREATMENT 4. WAS THERE ANY PHYSICAL HARM OR INJURY TO THE PATIENT DUE TO THE PROBLEM? NO"

Description of Event or Problem

IT WAS REPORTED THAT AFTER USING BD FACSCANTO¿ II ERRONEOUS RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT NOR ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CYTOMETER IS GIVING RARE POPULATIONS AND REQUIRES LACK OF SCALING AREA ADJUSTMENT. "1. WERE THERE ERRONEOUS RESULTS IN PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES, THE POPULATION WAS IDENTIFIED, BUT THE RESULT WAS NOT RELEASED TO THE PATIENT. 2. WAS THERE ANY DELAY IN TREATMENT DUE TO THE PROBLEM? THE SAMPLE WAS ORDERED TO BE SUBROGATED. 3. IF PATIENTS WERE RE-SAMPLED, WERE THERE ANY CHANGES OR DELAYS IN TREATMENT? THE SAMPLES WERE SUBROGATED AND THE APPROPRIATE RESULT WAS RELEASED, THERE WAS NO WRONG TREATMENT 4. WAS THERE ANY PHYSICAL HARM OR INJURY TO THE PATIENT DUE TO THE PROBLEM? NO".

Additional Manufacturer Narrative

H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE SCALING MISADJUSTMENT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE OF THE SCALING MISADJUSTMENT WAS PMT FAILURE. THE CUSTOMER REPORTED A COMPLAINT REGARDING SCALING MISADJUSTMENT. IN ORDER TO RESOLVE THE ISSUE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE PMT AND PERFORMED A SERIES OF TESTS TO VERIFY THE OPERATION. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS TESTED AND MEETING SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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.