KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

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 WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ASAN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INCUBATION TIME, 4 LINES WERE APPEARED ON THE CARTRIDGE, AND VERITOR PLUS ANALYSIS GAVE POSITIVE RESULTS. CUSTOMER RAN 2ND TIMES WITH SAME SAMPLE ON ANOTHER BD VERITOR FLU A/B CARTRIDGE AND COMPARE TO A COMPETITOR FLU A/ BD TRIP (ASAN). "

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0111862. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE OR DISCREPANT RESULTS 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 PROVIDED CONFIRMS WITH THE REPORT OF FALSE POSITIVE OR DISCREPANT RESULTS. NO TREND AGAINST FALSE POSITIVE OR DISCREPANT RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ASAN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INCUBATION TIME, 4 LINES WERE APPEARED ON THE CARTRIDGE, AND VERITOR PLUS ANALYSIS GAVE POSITIVE RESULTS. CUSTOMER RAN 2ND TIMES WITH SAME SAMPLE ON ANOTHER BD VERITOR FLU A/B CARTRIDGE AND COMPARE TO A COMPETITOR FLU A/ BD TRIP (ASAN). "