KIT FLU VERITOR SYSTEM 30 TEST JAPAN

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: "IT WAS REPORTED WHILE TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS OCCURRED 2 TIMES."

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS OCCURRED 2 TIMES.

Additional Manufacturer Narrative

D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. A DEVICE EVALUATION IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING (B)(6) 2023¿2025, UNDER CAPA 11910483.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL#: 256052), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT THERE WAS A THIN LINE-LIKE CRACK THAT WAS OBSERVED ON THE A LINE OF THE TEST CARTRIDGE, WHICH WAS READ AS POSITIVE. THE SAME EXTRACT WAS INOCULATED ONTO ANOTHER CARTRIDGE THAT THEN GAVE A NEGATIVE RESULT. 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. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. FROM THE 4 PHOTOS PROVIDED, 1 PHOTO SHOWS 4 DEVICES WITH AN EXTREMELY FAINT LINE AROUND COLUMN A. IT IS DIFFICULT TO DISTINGUISH WHETHER IT IS A LINE OR A SCRATCH. SINCE NO PHOTOS OF THE VERITOR ANALYZER RESULTS WERE RETURNED, WE ARE UNABLE TO CONFIRM THE COMPLAINT THROUGH THE PROVIDED PHOTOS. A TREND ANALYSIS FOR FALSE POSITIVE 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 TESTING WITH KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A CRACK ON THE TEST CARTRIDGE WHICH WAS VISUALLY INTERPRETED AS A POSITIVE. THE TEST WAS REPEATED WITH THE SAME SAMPLE AND THE RESULT WAS NEGATIVE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS OCCURRED 2 TIMES.