BD VERITOR¿ PLUS ANALYZER

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD VERITOR PLUS ANALYZER IS HAVING MULTIPLE RESULTS FALSE POSITIVE FOR FLU B. (CATALOG NUMBER 256066, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THEY OBTAINED 3 FALSE POSITIVE RESULTS, AND THEY HAD REPEATED THE TEST WITH PCR WHICH SHOWED AS NEGATIVE. REPLACEMENT ANALYZER WAS PROVIDED TO THE CUSTOMER. THE DEFECTIVE ANALYZER HAD BEEN RETURNED BY THE CUSTOMER; HOWEVER, BD QUALITY DID NOT RECEIVE THE UNIT FOR INVESTIGATION. IF THE ANALYZER IS RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. HOWEVER, RELATED COMPLAINT (B)(4) HAD BEEN INVESTIGATED, AND IT WAS FOUND THAT THE ISSUE WAS NOT DUE TO AN ANALYZER. THUS, THE 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.

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD VERITOR¿ PLUS ANALYZER, THE CUSTOMER RECEIVED THREE (3) FALSE POSITIVE FLU B PATIENT RESULTS. THE ERRONEOUS RESULTS WERE REPORTED. UPON SAMPLE RECOLLECTION AND RETESTING THE PATIENTS USING PCR, NEGATIVE FLU B RESULTS WERE OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD VERITOR¿ PLUS ANALYZER, THE CUSTOMER RECEIVED THREE (3) FALSE POSITIVE FLU B PATIENT RESULTS. THE ERRONEOUS RESULTS WERE REPORTED. UPON SAMPLE RECOLLECTION AND RETESTING THE PATIENTS USING PCR, NEGATIVE FLU B RESULTS WERE OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD VERITOR¿ PLUS ANALYZER, THE CUSTOMER RECEIVED THREE (3) FALSE POSITIVE FLU B PATIENT RESULTS. THE ERRONEOUS RESULTS WERE REPORTED. UPON SAMPLE RECOLLECTION AND RETESTING THE PATIENTS USING PCR, NEGATIVE FLU B RESULTS WERE OBTAINED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.