BD KIT FLU VERITOR SYSTEM 30 TEST JAPAN

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 24-OCT-2025. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL#: 256052), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT THE ANALYZER RETURNED A FLU B POSITIVE RESULT, HOWEVER THERE IS NO FLU B LINE VISIBLE. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE NOT PERFORMED AS THERE WAS NO BATCH NUMBER PROVIDED. PHOTOS AND RETURN SAMPLES WERE RECEIVED. TWO PHOTOGRAPHS WERE RETURNED OF THE CARTRIDGE AND SHOWED VISIBLE CONTROL LINE ONLY; HOWEVER, THE ISSUE OF DISCREPANT RESULT CANNOT BE CONFIRMED THROUGH THIS IMAGE ALONE, WITHOUT ANALYZER DATA. THERE WERE TWO USED TEST CARTRIDGES RECEIVED WITHOUT ANY OTHER KIT COMPONENTS. ADDITIONALLY, PER INTERNAL PROCEDURE, USED TEST CARTRIDGES WILL NOT BE EXAMINED AND MUST BE DISPOSED OF. INVESTIGATION WAS UNABLE TO BE PERFORMED WITH THE RETURN SAMPLES. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THE VERITOR ANALYZER PROVIDED A POSITIVE FLU B RESULT FOR ONE (1) PATIENT SAMPLE. HOWEVER, THE USER VISUALLY OBSERVED NO FLU B LINE ON THE TEST CARTRIDGE AND QUESTIONED THE POSITIVE RESULT. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E1. INITIAL REPORTER FACILITY NAME: (B)(6). 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 WHILE USING THE BD KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THE VERITOR ANALYZER PROVIDED A POSITIVE FLU B RESULT FOR ONE (1) PATIENT SAMPLE. HOWEVER, THE USER VISUALLY OBSERVED NO FLU B LINE ON THE TEST CARTRIDGE AND QUESTIONED THE POSITIVE RESULT. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.