BIOFIRE JOINT INFECTION PANEL

Additional Manufacturer Narrative

INVESTIGATION: (B)(6) AUSTRIA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE® JOINT INFECTION (JI) PANEL AFTER TESTING A BIOPSY SAMPLE FROM A 47-YEAR-OLD FEMALE PATIENT. THE SAMPLE TYPE UTILIZED IS CONSIDERED OFF-LABEL USE OF THE DEVICE, THEREFORE, THE EXPECTED PERFORMANCE OF DEVICE IS UNKNOWN. REGARDLESS OF OFF-LABEL USE, INVESTIGATION IDENTIFIED A POTENTIAL PRODUCT MALFUNCTION. THE CUSTOMER STATED THAT THE PATIENT WAS NOT HARMED DUE TO THE JI PANEL RESULT. THE ANALYSIS OF THE DISCREPANT JI PANEL RUN FILE PROVIDED SHOWED BY THE CUSTOMER SHOWED LATE SIGNATURE, SUGGESTING THAT THE TARGET NUCLEIC ACID WAS PRESENT AT LOW LEVELS. QC RECORDS FOR KIT/POUCH LOT 0878825/3RXZ25 AND INSTRUMENT 2FA08577 WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA. THE FILMARRAY INSTRUMENT PASSED QC AND WAS WORKING WITHIN DESIGN SPECIFICATIONS. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. AUREUS RESULT AT THE CUSTOMER SITE WAS DUE TO REAGENT POUCH CONTAMINATION DURING MANUFACTURING. ANALYSIS OF THE RUN FILE PROVIDED BY THE CUSTOMER AND IN-HOUSE INVESTIGATION OF THE BIOFIRE JI PANEL POUCH LOT INDICATE A POTENTIAL LOW-LEVEL CONTAMINATION EVENT DURING THE MANUFACTURING OF THIS LOT. OFF-LABEL USE REMAINS A POSSIBLE CAUSE OF THIS EVENT; HOWEVER, A PRODUCT MALFUNCTION COULD NOT BE RULED OUT AS A POSSIBLE CAUSE BASED ON THE PROVIDED RUN FILES. FALSE POSITIVE AND FALSE NEGATIVE RESULTS CAN BE THE RESULT OF A VARIETY OF SOURCES AND CAUSES, IT IS IMPORTANT THAT THESE RESULTS BE USED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, OR LABORATORY INFORMATION. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 20, 49, AND 50 OF THE BIOFIRE® JOINT INFECTION (JI) PANEL INSTRUCTIONS FOR USE (HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/US/EN/ALL?KEYCODE=ITI0017).

Description of Event or Problem

SUMMARY: THE CUSTOMER (ZAMS, AUSTRIA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE® JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT BIOPSY SAMPLE. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT DUE TO THE JI PANEL RESULT, AND THE CUSTOMER STATED THE PATIENT WAS NOT HARMED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY THE CAUSE OF THE FALSE POSITIVE S. AUREUS RESULT WAS CONTAMINATION DURING MANUFACTURING