BD VERITOR¿ SYSTEM FLU A+B ASSAY

Additional Manufacturer Narrative

NOTE THAT THE DEVICE LISTED DOES NOT HAVE A 510(K) AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE 510(K) 256041. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A FALSE POSITIVE WAS OBTAINED WHILE USING THE BD VERITOR¿ SYSTEM FLU A+B ASSAY CAUSING ERRONEOUS RESULTS. ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT IMPACT. THIS EVENT OCCURRED ON 38 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REAGENT DID NOT FLOW PROPERLY, WHICH CAUSED ERRONEOUS RESULTS. ·FALSE POSITIVE WAS SUSPECTED BY THE TECHNICIAN, BECAUSE HE/SHE COULD NOT SEE ANY LINE ON TEST PLATE AND FLOW ISSUE MIGHT BE OCCURRED. ·THE POSITIVE RESULT WAS REPORTED TO THE DOCTOR AS ANALYZER REPORTED AS POSITIVE(DUE TO THE QUALITY CONTROL RULES IN THE HOSPITAL, VISUAL JUDGMENT IS COMPLETELY PROHIBITED) ·NO ADVERSE CONSEQUENCE WAS REPORTED WITH THIS ISSUE FROM THE HOSPITA.L

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT VERITOR FLU HOSPITAL 30 TEST JAPAN (MN# 256072), BATCH NUMBER 9309888. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETURNED PHOTOGRAPHIC EVIDENCE PROVIDED DID NOT CONFIRM THE CUSTOMER¿S REPORT OF FALSE POSITIVE. THE REPORTED ISSUE WAS NOT DUPLICATED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT A FALSE POSITIVE WAS OBTAINED WHILE USING THE BD VERITOR¿ SYSTEM FLU A+B ASSAY CAUSING ERRONEOUS RESULTS. ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT IMPACT. THIS EVENT OCCURRED ON 38 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REAGENT DID NOT FLOW PROPERLY, WHICH CAUSED ERRONEOUS RESULTS. FALSE POSITIVE WAS SUSPECTED BY THE TECHNICIAN, BECAUSE HE/SHE COULD NOT SEE ANY LINE ON TEST PLATE AND FLOW ISSUE MIGHT BE OCCURRED. THE POSITIVE RESULT WAS REPORTED TO THE DOCTOR AS ANALYZER REPORTED AS POSITIVE(DUE TO THE QUALITY CONTROL RULES IN THE HOSPITAL, VISUAL JUDGMENT IS COMPLETELY PROHIBITED) . NO ADVERSE CONSEQUENCE WAS REPORTED WITH THIS ISSUE FROM THE HOSPITAL.