BD MULTITEST¿

Additional Manufacturer Narrative

H.6: INVESTIGATION SUMMARY BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE (NON-SPECIFIC STAINING CREATING UNUSUAL STAINING PATTERNS FOR CD4+CD+8 POPULATIONS) WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: - DATA PROVIDED BY CUSTOMER WAS REVIEWED. - RETAIN TESTING RESULTS SHOWED THE PRESENCE OF A NON-SPECIFIC STAINING. - POTENTIAL CAUSE IS DETERMINED TO BE MANUFACTURING RELATED. - ADDITIONAL CONTROLS HAVE BEEN PUT IN PLACE IN THE MANUFACTURING STAGE SPECIFIC TO THE SUPPLIED COMPONENT. - CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ROOT CAUSE AND PREVENTIVE ACTIONS. 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 THE BD MULTITEST¿ 58 OCCURRENCES OF ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF PATIENT INFORMATION OR IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - PATIENT SAMPLES (CASE) 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? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IND IS EXPERIENCING AN INTERMITTENT ISSUE WITH AN ISSUE WITH OUR TBNK RUNS (AS SEEN BELOW; APOLOGIES FOR THE SCAN QUALITY). WE ARE SEEING WHAT LOOKS TO BE AUTOFLUORESCENT POPULATIONS IN THE CD4/CD8 DOUBLE POSITIVE AND CD19/CD16+CD56 TRIPLE POSITIVE GATES. AS MENTIONED EARLIER IN THE EMAIL, THIS IS AN INTERMITTENT ISSUE SEEN IN BOTH THE QC AND SAMPLES. IT IS ACROSS SEVERAL INSTRUMENTS AND SPAS AS WELL AS SEEN IN MANUAL AND SPA PREPARATIONS OF THE SAMPLES. WE HAVE COMPLETED A QUICK TEST TO SEE IF A NEW LOT ON-SITE DOESN¿T PRESENT WITH THIS ISSUE. IT APPEARS THAT THE CURRENT LOT OF REAGENT MAY CONTAIN DEBRIS (DEEP RED POPULATION BELOW ON FCSE PLOTS) OR CAUSING INCREASED DEBRIS LEADING TO THESE ABNORMAL POPULATIONS.

Additional Manufacturer Narrative

G.5. PMA / 510(K)#: K090967. G.5. PMA / 510(K)#: K170974. H.3. A DEVICE EVALUATION AND OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD MULTITEST¿ 58 OCCURRENCES OF ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF PATIENT INFORMATION OR IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST: PATIENT SAMPLES (CASE). 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? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. IND IS EXPERIENCING AN INTERMITTENT ISSUE WITH AN ISSUE WITH OUR TBNK RUNS (AS SEEN BELOW; APOLOGIES FOR THE SCAN QUALITY). WE ARE SEEING WHAT LOOKS TO BE AUTOFLUORESCENT POPULATIONS IN THE CD4/CD8 DOUBLE POSITIVE AND CD19/CD16+CD56 TRIPLE POSITIVE GATES. AS MENTIONED EARLIER IN THE EMAIL, THIS IS AN INTERMITTENT ISSUE SEEN IN BOTH THE QC AND SAMPLES. IT IS ACROSS SEVERAL INSTRUMENTS AND SPAS AS WELL AS SEEN IN MANUAL AND SPA PREPARATIONS OF THE SAMPLES. WE HAVE COMPLETED A QUICK TEST TO SEE IF A NEW LOT ON-SITE DOESN¿T PRESENT WITH THIS ISSUE. IT APPEARS THAT THE CURRENT LOT OF REAGENT MAY CONTAIN DEBRIS (DEEP RED POPULATION BELOW ON FCSE PLOTS) OR CAUSING INCREASED DEBRIS LEADING TO THESE ABNORMAL POPULATIONS.