BD VIPER¿ SYSTEM
Received May 19, 2023 · Event occurred Apr 24, 2023
Report 1119779-2023-00578 · MDR key 16969910
Device
Generic name
Dna Reagents, Neisseria
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
441091Catalog number
441091
Product problems
- False Negative Result
- False Negative Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD VIPER¿ SYSTEM HAS HAD AN INCREASE OF SALE NEGATIVE SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMED THAT HAS NOTICE AN INCREASE OF FALSE NEGATIVES SAMPLES. THE INTERNAL CONTROLS PASS BUT REPEATING A DUMMY RUN WITH ALREADY KNOWN POSITIVE SAMPLES, ONE BECAME NEGATIVE AND ONE POSITIVE WITH A LOW VALUE.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD VIPER XTR INSTRUMENT (CATALOG NUMBER 441091 AND SERIAL NUMBER (B)(6)) HAD "FALSE NEGATIVES". CUSTOMER REPORTED THAT THEY HAVE NOTICED AN INCREASE IN SUSPECTED FALSE NEGATIVE RESULTS AND THAT INTERNAL CONTROLS PASS BUT REPEAT TESTING OF KNOWN POSITIVE SAMPLES SOMETIMES GIVES A NEGATIVE RESULT. REMOTE ASSISTANCE WAS PROVIDED TO THE CUSTOMER TO HELP INVESTIGATE THE ISSUE. NO INSTRUMENT ISSUES WERE IDENTIFIED BY SERVICE, AND IT WAS DETERMINED THAT THE ISSUE IT LIKELY CAUSED BY A BUILD-UP OF BLEACH RESIDE ON THE INSTRUMENT WHICH CAN CAUSE LOW LEVEL ASSAY INHIBITION. THIS COMPLAINT IS UNCONFIRMED AS IT ALLUDES TO A CLEANING WORKFLOW ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE ASSAY TARGET INHIBITION. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE COMPLAINT IS UNCONFIRMED, THUS A DHR REVIEW WOULD YIELD NO USEFUL INFORMATION. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED.
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 BD VIPER¿ SYSTEM HAS HAD AN INCREASE OF SALE NEGATIVE SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMED THAT HAS NOTICE AN INCREASE OF FALSE NEGATIVES SAMPLES. THE INTERNAL CONTROLS PASS BUT REPEATING A DUMMY RUN WITH ALREADY KNOWN POSITIVE SAMPLES, ONE BECAME NEGATIVE AND ONE POSITIVE WITH A LOW VALUE.