BD MULTITEST¿ 6-COLOR TBNK

Additional Manufacturer Narrative

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 BD MULTITEST¿ 6-COLOR TBNK ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , APC VS SSC ,CD19 VS CD16+56 AND CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761 ADDITIONAL INFORMATION RECEIVED BY CUSTOMER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES, THAT IS CORRECT.

Additional Manufacturer Narrative

E.1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ 6-COLOR TBNK ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC , APC VS SSC ,CD19 VS CD16+56 AND CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761. ADDITIONAL INFORMATION RECEIVED BY CUSTOMER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES, THAT IS CORRECT.