BD FACSCANTO¿ II

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II. 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? (GO TO QUESTION #3): UNKNOWN. 3 IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4 WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): UNKNOWN. CUSTOMER HAS TRIED TWO DIFFERENT LOTS OF TRUCOUNT AND THE PROBLEM OCCURS WITH BOTH. IT DOES NOT HAVE 7 COLOR SETUPS TO CHECK THE TECHNICAL PERFORMANCE OF THE INSTRUMENT WITH THE CANTO CLINICAL. I ASK YOU TO RUN AT LEAST THE CST, WHICH DO NOT HIGHLIGHT ANY PROBLEMS . I PASS THE CASE TO SATA. IN THE TBNK ESSAY THE TRUCOUNT MARBLES DO NOT LAND IN THE GATE THEY SHOULD LAND IN AND ARE VERY SCATTERED

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. 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

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: PATIENT ANNEX CODE WAS CORRECTED TO F26. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: (B)(4). MANUFACTURING SITE CONTACT: (B)(4). H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE WRONG TRUCOUNT COUNT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : DHR WAS REVIEWED TO CONFIRM THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATION PRIOR TO RELEASE. THE POTENTIAL CAUSE OF WRONG TRUCOUNT COUNT WAS DIRTY FILTERS. THE CUSTOMER REPORTED AN ISSUE REGARDING INCORRECT TRUCOUNT COUNT. IN THE TBNK ASSAY, THE TRUCOUNT DOES NOT LAND IN THE APPROPRIATE GATES AND WERE SCATTERED. THE CASE WAS TRANSFERRED TO APPLICATION SPECIALIST. THE PROBLEM WAS RESOLVED AFTER FOLLOWING THE ADVICE OF THE APPLICATION SPECIALIST AND PURGING AIR OUT OF THE SHEATH FILTER. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS PERFORMING AS INTENDED. 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.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSCANTO¿ II. 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? (GO TO QUESTION #3): UNKNOWN. 3 IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4 WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): UNKNOWN. CUSTOMER HAS TRIED TWO DIFFERENT LOTS OF TRUCOUNT AND THE PROBLEM OCCURS WITH BOTH. IT DOES NOT HAVE 7 COLOR SETUPS TO CHECK THE TECHNICAL PERFORMANCE OF THE INSTRUMENT WITH THE CANTO CLINICAL. I ASK YOU TO RUN AT LEAST THE CST, WHICH DO NOT HIGHLIGHT ANY PROBLEMS (SEE ATTACHMENT). I PASS THE CASE TO (B)(6). IN THE TBNK ESSAY THE TRUCOUNT MARBLES DO NOT LAND IN THE GATE THEY SHOULD LAND IN AND ARE VERY SCATTERED.