FILMARRAY® PNEUMONIA PANEL PLUS
Report
- Report Number
- 3002773840-2025-00014
- Event Type
- Injury
- Date Received
- March 13, 2025
- Date of Event
- December 23, 2024
- Report Date
- April 10, 2025
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- QDS
- PMA / PMN Number
- K243222
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: THE PATIENT WAS A 72-YEAR-OLD, FEMALE IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SEDATED AND INTUBATED AT THE TIME OF TESTING. THE CUSTOMER REPORTED X-RAY SHOWED PNEUMONIA. ON (B)(6) 2024, THE PATIENT'S SPUTUM SAMPLE WAS TESTED ON THE FILMARRAY PNEUMONIA PANEL PLUS PANEL. THE FILMARRAY PNEUMONIA PANEL PLUS REPORTED ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, STAPHYLOCOCCUS AUREUS, SERRATIA MARCESCENS, CTX-M, IMP, NDM, AND VIM. THE SAME SAMPLE WAS USED FOR ADDITIONAL TESTING. E. COLI ESBL, S. AUREUS, AND CANDIDA SPP. WERE RECOVERED FROM CULTURE. NOTE, THE FILMARRAY PNEUMONIA PANEL PLUS DOES NOT DETECT CANDIDA. THE CUSTOMER STATED THAT DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS, COLISTIN WAS ADMINISTERED CAUSING KIDNEY DAMAGE. THE CUSTOMER REPORTS THE PATIENT WAS HARMED. COLISTIN WAS DISCONTINUED AFTER CULTURE DETERMINED THE ANALYTES WERE CARBAPENEMASE SENSITIVE 72 HOURS LATER. THE ANALYSIS OF THE FILMARRAY PNEUMONIA PANEL PLUS RUN FILE SHOWED LATE AMPLIFICATION SIGNATURES FOR S. MARCESCENS AND E. CLOACAE ASSAYS, INDICATING LOW LEVELS OF TARGET NUCLEIC ACIDS IN THE CLINICAL SAMPLES. ADDITIONALLY, THE AMPLIFICATION SIGNATURES OF THE DISCREPANT AMR GENES WERE ALSO LATE, SUGGESTING THE POSSIBILITY THAT THESE SIGNATURES MAY BE ASSOCIATED WITH AN ORGANISM NOT DETECTED BY FILMARRAY PNEUMONIA PANEL PLUS OR WERE POTENTIALLY INTRODUCED THROUGH CONTAMINATION. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 37BT24 (KIT LOT# 0202124) WERE REVIEWED. THE POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE AND THE FILMARRAY INSTRUMENT (SERIAL NUMBER# (B)(6)) WAS WORKING WITHIN DESIGNED SPECIFICATIONS. CONCLUSION: THE MOST LIKELY CAUSE OF THE DISCREPANCY WAS 1) CONTAMINATION AND/OR 2) COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN FILMARRAY PNEUMONIA PANEL PLUS AND PHENOTYPIC METHODS. 1) DUE TO THE SENSITIVE NATURE OF THE FILMARRAY PNEUMONIA PANEL PLUS, THERE IS A RISK OF FALSE POSITIVE RESULTS FROM THE INTRODUCTION OF EXOGENOUS ORGANISMS OR NUCLEIC ACIDS. WHILE THE POUCH LOADING INSTRUCTIONS AND RECOMMENDED CLEANING STEPS ARE SUFFICIENT TO ELIMINATE CONTAMINATION THE MAJORITY OF THE TIME, IT IS POSSIBLE THAT SOME ORGANISMS/NUCLEIC ACIDS COULD BE INTRODUCED DURING ANY PART OF THE TESTING AND POUCH HANDLING PROCESS. CONTAMINATION CAN ALSO BE INTRODUCED VIA THE LABORATORY ENVIRONMENT AND EQUIPMENT SUCH AS PIPETTES, PIPETTE TIPS, ETC., OR PERSONNEL HANDLING THE SAMPLE. IMPORTANTLY, IT WAS NOTED THAT NO DECONTAMINATION PROCEDURE WAS BEING PERFORMED AT THE CUSTOMER SITE. TO MINIMIZE THE RISK OF CONTAMINATION AND FALSE POSITIVE RESULTS, BIOFIRE RECOMMENDS PERFORMING DECONTAMINATION BETWEEN SPECIMENS USING AN APPROPRIATE DISINFECTANT, SUCH AS 10% BLEACH, FOLLOWED BY RINSING WITH WATER. BIOFIRE ALSO RECOMMENDS LOADING POUCHES INSIDE A BIOSAFETY CABINET OR OTHER CONTAINMENT SYSTEM TO REDUCE THE LIKELIHOOD OF CONTAMINATION. IF FALSE-POSITIVE RESULTS OCCUR AND CONTAMINATION IS SUSPECTED, BIOFIRE RECOMMENDS PERFORMING ENVIRONMENTAL TESTING OR SWABS OF THE AREA WHERE FILMARRAY PNEUMONIA PANEL PLUS TESTING IS CONDUCTED TO IDENTIFY POTENTIAL SOURCES OF CONTAMINATION. IMPLEMENTING THESE BEST PRACTICES CAN HELP ENSURE THE ACCURACY OF RESULTS AND REDUCE THE RISK OF CONTAMINATION IN FUTURE TESTING. FALSE POSITIVE RESULTS CAN BE CAUSED BY CONTAMINATION OF SPECIMENS OR THE TEST WITH ORGANISMS SHED BY OTHERWISE HEALTHY INDIVIDUALS. TO MINIMIZE THE RISK OF FALSE POSITIVE RESULTS DUE TO CONTAMINATION, CAUTION SHOULD BE EXERCISED DURING SPECIMEN COLLECTION AND TESTING. PARTICULAR ATTENTION SHOULD BE GIVEN TO THE LABORATORY PRECAUTIONS NOTED UNDER THE "WARNINGS AND PRECAUTIONS" SECTION OF THE FILMARRAY PNEUMONIA PANEL PLUS INSTRUCTIONS FOR USE (WWW.ONLINE-IFU.COM/ITI0038), AS WELL AS THE "CONTAMINATION PREVENTION AND DECONTAMINATION" TECHNICAL NOTE [FLM1-PRT-0230], TO AVOID POSSIBLE CONTAMINATION. SAMPLES SHOULD BE PROCESSED IN A CLEAN BIOSAFETY CABINET IF AVAILABLE OR ACCORDING TO LOCAL LABORATORY GUIDELINES. IF A BIOSAFETY CABINET IS NOT USED, A DEAD AIR BOX (E.G., AIRCLEAN PCR WORKSTATION), A SPLASH SHIELD (E.G., BEL-ART SCIENCEWARE SPLASH SHIELDS), OR A FACE SHIELD CAN BE USED WHEN PREPARING SAMPLES INSTEAD. 2) THE FALSE POSITIVE RESULT FOR S. MARCESCENS AND E. CLOACAE MAY BE DUE TO THE PRESENCE OF A POLYMICROBIAL CULTURE. RUN FILE ANALYSIS SHOWED LATE AMPLIFICATION SIGNATURES, INDICATING LOW LEVELS OF TARGET NUCLEIC ACID IN THE SAMPLE COMPARED TO OTHER ANALYTES. IT IS POSSIBLE THAT THESE ORGANISMS WERE PRESENT IN THE SAMPLES BUT DID NOT GROW TO A DETECTABLE LEVEL USING TRADITIONAL CULTURE METHODS. THE RUN FILE ANALYSIS ALSO DETECTED AMR GENE TARGETS WITH LATE SIGNATURES, SUGGESTING THAT THESE ANTIMICROBIAL RESISTANCE NUCLEIC ACID SEQUENCES WERE PRESENT AT LOW CONCENTRATIONS. NO CARBAPENEMASE GENES WERE DETECTED IN CULTURE WHICH MAY BE ATTRIBUTED TO SENSITIVITY AND SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY PNEUMONIA PANEL PLUS MOLECULAR DETECTION METHOD AND STANDARD PHENOTYPIC CULTURE METHODS. AS OUTLINED IN THE FILMARRAY PNEUMONIA PANEL PLUS IFU, ANTIMICROBIAL RESISTANCE CAN OCCUR VIA MULTIPLE MECHANISMS. A NOT DETECTED RESULT FOR A GENETIC MARKER OF ANTIMICROBIAL RESISTANCE DOES NOT INDICATE SUSCEPTIBILITY TO THE ASSOCIATED ANTIMICROBIAL DRUGS OR DRUG CLASSES. CONVERSELY, A DETECTED RESULT FOR A GENETIC MARKER OF ANTIMICROBIAL RESISTANCE CANNOT BE DEFINITIVELY LINKED TO THE MICROORGANISMS DETECTED. CULTURE IS REQUIRED TO OBTAIN ISOLATES FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING, AND FILMARRAY PNEUMONIA PANEL PLUS RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH CULTURE RESULTS TO DETERMINE SUSCEPTIBILITY OR RESISTANCE. DUE TO THE HIGH SENSITIVITY AND SPECIFICITY OF THE FILMARRAY PNEUMONIA PANEL PLUS AND ITS ABILITY TO DETECT ORGANISMS DIRECTLY FROM THE PATIENT'S SAMPLE RATHER THAN FROM ISOLATED CULTURE COLONIES, DISCREPANCIES WITH STANDARD IDENTIFICATION TECHNIQUES CAN OCCUR AND ARE PART OF NORMAL SYSTEM PERFORMANCE. FALSE POSITIVES AND FALSE NEGATIVES CAN BE THE RESULT OF A VARIETY OF SOURCES AND CAUSES. IT IS IMPORTANT THAT RESULTS BE USED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, OR LABORATORY INFORMATION.
INVESTIGATION: FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE ENTEROBACTER CLOACAE COMPLEX, SERRATIA MARCESCENS, IMP, NDM, AND VIM RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN, WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. CONCLUSION: INVESTIGATION ONGOING.
SUMMARY: FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE ENTEROBACTER CLOACAE COMPLEX, SERRATIA MARCESCENS, IMP, NDM, AND VIM RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN, WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. THE MOST LIKELY CAUSE OF THE DISCREPANCY WAS 1) CONTAMINATION AND/OR 2) COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN FILMARRAY PNEUMONIA PANEL PLUS AND PHENOTYPIC METHODS.
SUMMARY: FMPS HOLDING SAL (NACCACH, LEBANON) REPORTED A POTENTIAL FALSE POSITIVE ENTEROBACTER CLOACAE COMPLEX, SERRATIA MARCESCENS, IMP, NDM, AND VIM RESULT ON THE FILMARRAY PNEUMONIA PANEL PLUS AFTER TESTING A PATIENT'S SPUTUM SAMPLE. DUE TO THE FILMARRAY PNEUMONIA PANEL PLUS RESULT, THE PATIENT RECEIVED COLISTIN, WHICH MAY HAVE RESULTED IN KIDNEY DAMAGE. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2031681 | FILMARRAY® PNEUMONIA PANEL PLUS | FILMARRAY® PNEUMONIA PANEL PLUS | QDS | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0143 | 0202124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Other |