BD VERITOR¿ PLUS ANALYZER
Report
- Report Number
- 1119779-2025-00176
- Event Type
- Malfunction
- Date Received
- March 7, 2025
- Date of Event
- February 7, 2025
- Report Date
- September 11, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- PSZ
- UDI-DI
- 00382902560661
- PMA / PMN Number
- K232434
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN CORRECTED: D2. MEDICAL DEVICE TYPE: PSZ. COMMON DEVICE NAME: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS. G5. PMA / 510(K)#: K232434.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES. D9. RETURNED TO MANUFACTURER ON: 11-JUL-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY - THE COMPLAINT ALLEGES THE BD VERITOR PLUS ANALYZER IS HAVING DISCREPANT RESULTS FOR FLU A. (CATALOG NUMBER 256066, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THAT THEY OBTAINED POSITIVE FLU A IN THIS AFFECTED ANALYZER AND WHEN THEY HAD TESTED ON DIFFERENT ANALYZER, IT IS SHOWING AS NEGATIVE FOR FLU A. BD VERITOR PLUS ANALYZER WAS RETURNED FOR INVESTIGATION. TROUBLESHOOTING PERFORMED FOR THE RETURNED ANALYZER AND FOUND THERE WAS A SIGNAL ON THE TEST STRIP WHICH IS WHY THE RESULTS BEING READ AS POSITIVE FOR FLU A. THEREFORE, THIS COMPLAINT IS UNCONFIRMED. DEVICE HISTORY RECORD REVIEW FOR VERITOR PLUS ANALYZER, SERIAL NUMBER (B)(6) WAS REVIEWED AND NONCONFORMANCES RELATED TO THIS FAILURE MODE WERE NOT REVEALED IN MANUFACTURING DURING FINAL TESTING. THE DEVICE WAS RELEASED CONFORMING. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.
IT WAS REPORTED AFTER USING THE BD VERITOR¿ PLUS ANALYZER, THE USER QUESTIONED ONE (1) POSITIVE FLU A PATIENT RESULT AFTER REMOVING AND VISUALLY READING THE TEST CARTRIDGE. THE SAME TEST CARTRIDGE WAS REINSERTED INTO A SECOND ANALYZER AND A NEGATIVE FLU A RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED AFTER USING THE BD VERITOR¿ PLUS ANALYZER, THE USER QUESTIONED ONE (1) POSITIVE FLU A PATIENT RESULT AFTER REMOVING AND VISUALLY READING THE TEST CARTRIDGE. THE SAME TEST CARTRIDGE WAS REINSERTED INTO A SECOND ANALYZER AND A NEGATIVE FLU A RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED AFTER USING THE BD VERITOR¿ PLUS ANALYZER, THE USER QUESTIONED ONE (1) POSITIVE FLU A PATIENT RESULT AFTER REMOVING AND VISUALLY READING THE TEST CARTRIDGE. THE SAME TEST CARTRIDGE WAS REINSERTED INTO A SECOND ANALYZER AND A NEGATIVE FLU A RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907156 | BD VERITOR¿ PLUS ANALYZER | DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | PSZ | BECTON DICKINSON & CO. (SPARKS) | 00382902560661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |