BD MAX¿ ENTERIC BACTERIAL PANEL
Received Oct 6, 2023 · Event occurred Sep 8, 2023
Report 1119779-2023-01072 · MDR key 17889163
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
442963
Lot number
UNKNOWN
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT HAD "FALSE POSITIVES". CUSTOMER REPORTED THAT THEY ARE WITNESSING SUSPECTED FALSE POSITIVE RESULTS AS THEY ARE SEEING MANY DUAL TARGET POSITIVE SAMPLES WHILE RUNNING THE ENTERIC BACTERIAL PANEL ASSAY. CUSTOMER RUN DATA WAS PROVIDED TO BD SERVICE SPECIALISTS AND QUALITY FOR FURTHER ANALYSIS, WHICH REVEALED EVIDENCE OF CONTAMINATION. THE CUSTOMER WAS INSTRUCTED TO PERFORM ENVIRONMENTAL MONITORING OF THE LAB, WHICH CAME BACK POSITIVE. CUSTOMER WAS PROVIDED GUIDANCE ON CLEANING AND DECONTAMINATION PROCEDURE. THIS COMPLAINT IS UNCONFIRMED AS THE ANALYSIS OF THE INSTRUMENT DATABASE CONFIRMS THAT THE INSTRUMENT IS OPERATING TO SPECIFICATIONS. THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENTAL CONTAMINATION WITHIN THE LABORATORY. SAMPLES RECEIVED BY QUALITY FOR INVESTIGATION INCLUDED THE CUSTOMER RUN DATABASE FILES. REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSTRUMENT 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 AND NO ADDITIONAL CASES WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS EXPERIENCED AN INCREASE IN DUAL POSITIVE TARGETS WHEN USING THE BD MAX ENTERIC BACTERIAL PANEL.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS EXPERIENCED AN INCREASE IN DUAL POSITIVE TARGETS WHEN USING THE BD MAX ENTERIC BACTERIAL PANEL.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.