FILMARRAY ME PANEL
Report
- Report Number
- 3002773840-2025-00080
- Event Type
- Injury
- Date Received
- November 25, 2025
- Date of Event
- October 25, 2025
- Report Date
- December 18, 2025
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PLO
- UDI-DI
- 00815381020123
- PMA / PMN Number
- K160462
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: THE PATIENT WAS A 67-YEAR-OLD FEMALE IN THE ICU DEPARTMENT. THE PATIENT WAS IMMUNOCOMPROMISED WITH NASOPHARYNGEAL CARCINOMA BUT WAS STABLE AFTER CHEMOTHERAPY. THE PATIENT WAS DIAGNOSED WITH SEPTIC SHOCK AT ANOTHER HOSPITAL BEFORE BEING TRANSFERRED TO THE CUSTOMER SITE. AT THE TIME OF SAMPLE COLLECTION, THE PATIENT WAS BEING TREATED WITH MEROPENEM (1G X 6 VIALS/DAY). ON (B)(6) 2025, THE CSF SAMPLE FROM THE PATIENT WAS TESTED ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL. THE ME PANEL REPORTED ALL ANALYTES AS NOT DETECTED. THE PATIENT'S WBC WAS "+++." GRAM-NEGATIVE BACILLI WERE OBSERVED ON GRAM STAIN. E. COLI WAS RECOVERED FROM CULTURE AND IDENTIFIED VIA VITEK® 2. ON (B)(6) 2025, GRAM STAIN RESULT WAS REPORTED TO THE CLINICIAN AT 01:30, AND ME PANEL AT 08:48. THE CUSTOMER HAD INITIALLY COMMUNICATED THAT THAT THE PATIENT'S TREATMENT WAS DELAYED, THE PATIENT WAS HARMED, AND THE PATIENT WAS IN COMA AND RECEIVING MECHANICAL VENTILATION. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION STATING THE PATIENT WAS ON MEROPENEM BEFORE THE ME PANEL RESULT WAS PROVIDED AND REMAINED ON MEROPENEM WHEN THE ALLEGED FALSE NEGATIVE WAS REPORTED. PATIENT MANAGEMENT WAS NOT MODIFIED BASED ON THE DISCREPANT ME PANEL RESULT. THE PATIENT'S FINAL DIAGNOSIS WAS "SEPTIC SHOCK, COMA, BACTERIAL MENINGITIS CAUSED BY E. COLI, NASOPHARYNGEAL CARCINOMA - STABLE AFTER CHEMOTHERAPY." THE ANALYSIS OF THE ME PANEL RUN FILE SHOWED FLAT LINE SIGNATURES FOR THE E. COLI K1 ASSAY, SUGGESTING THAT NUCLEIC ACID WAS NOT PRESENT FOR THE TARGET OF THIS ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3SUT25 (KIT LOT# 1047225) WERE REVIEWED. THIS 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 INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT E. COLI K1 RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE ME PANEL AND CULTURE. IT IS LIKELY THAT AN OFF-PANEL STRAIN OF E. COLI WAS PRESENT IN THE SAMPLE AND THE ME PANEL WAS FUNCTIONING AS INTENDED. ACCORDING TO THE ME PANEL'S INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0035), THE ME PANEL ONLY IDENTIFIES E. COLI STRAINS POSSESSING THE K1 CAPSULAR ANTIGEN; ALL OTHER E. COLI STRAINS/SEROTYPES WILL NOT BE DETECTED. ALTHOUGH RARE, DISCREPANCIES BETWEEN ME PANEL AND COMPARATOR TESTING ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT AND NEGATIVE RESULTS SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER MANAGEMENT DECISIONS. THE DETECTION OF TARGET NUCLEIC ACID DEPENDS UPON PROPER HANDLING, STORAGE, AND THE PREPARATION OF THE SAMPLE. FAILURE TO OBSERVE PROPER PROCEDURES IN ANY ONE OF THESE STEPS CAN LEAD TO INCORRECT RESULTS. BIOFIRE RECOMMENDS THAT RESULTS FROM THE ME PANEL SHOULD BE USED IN CONJUNCTION WITH AND CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. THE ME PANEL IS A QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED IN VITRO DIAGNOSTIC TEST INTENDED FOR USE WITH FILMARRAY SYSTEMS. THE ME PANEL IS CAPABLE OF SIMULTANEOUS DETECTION AND IDENTIFICATION OF MULTIPLE BACTERIAL, VIRAL, AND YEAST NUCLEIC ACIDS DIRECTLY FROM CSF SPECIMENS OBTAINED VIA LUMBAR PUNCTURE FROM INDIVIDUALS WITH SIGNS AND/OR SYMPTOMS OF MENINGITIS AND/OR ENCEPHALITIS. NOTE: THE CUSTOMER STATED THAT THE PATIENT WAS UNDERGOING CHEMOTHERAPY FOR A NASOPHARYNGEAL CARCINOMA AND WAS IMMUNOCOMPROMISED AT THE TIME OF THE CSF SAMPLE COLLECTION. ACCORDING TO THE ME PANEL INSTRUCTION BOOKLET, THE PERFORMANCE OF THE ME PANEL HAS NOT BEEN SPECIFICALLY EVALUATED FOR CSF SPECIMENS COLLECTED FROM IMMUNOCOMPROMISED INDIVIDUALS. ADDITIONALLY, THE CUSTOMER STATED THE PATIENT RECEIVED TREATMENT PRIOR TO THE CSF SAMPLE COLLECTION. ACCORDING TO THE ME PANEL INSTRUCTION BOOKLET, THE PERFORMANCE OF THE ME PANEL HAS NOT BEEN SPECIFICALLY EVALUATED FOR CSF SPECIMENS COLLECTED FROM INDIVIDUALS ON ANTIMICROBIAL TREATMENT. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 9, 14, AND 15 OF THE ME PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0035).
INVESTIGATION: NATIONAL HOSPITAL FOR TROPICAL DISEASES (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI K1 (E. COLI K1) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CSF SAMPLE FROM A 67-YEAR-OLD, FEMALE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS HARMED AS A CONSEQUENCE OF THE ERRONEOUS RESULT. BIOFIRE MEDICAL AFFAIRS TEAM IS CURRENTLY ASSESSING THE CASE. ADDITIONALLY, 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: N/A FOR INITIAL REPORT.
SUMMARY: (B)(6), (VIETNAM) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI K1 (E. COLI K1) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CSF SAMPLE FROM A 67-YEAR-OLD, FEMALE PATIENT. THE PATIENT WAS NOT AFFECTED DUE TO THE DISCREPANT ME PANEL RESULT. THE CUSTOMER HAD INITIALLY COMMUNICATED THAT THAT THE PATIENT'S TREATMENT WAS DELAYED, THE PATIENT WAS HARMED, AND THE PATIENT WAS IN COMA AND RECEIVING MECHANICAL VENTILATION. IT WAS UNCLEAR WHETHER THE PATIENT¿S COMA AND NEED FOR MECHANICAL VENTILATION WERE RELATED TO THE ME PANEL RESULT; THEREFORE, AN INITIAL REPORT WAS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. HOWEVER, THE CUSTOMER LATER CLARIFIED THAT THE PATIENT'S TREATMENT WAS NOT AFFECTED DUE TO THE ME PANEL. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT E. COLI K1 RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE ME PANEL AND CULTURE.
SUMMARY: (B)(6) HOSPITAL FOR TROPICAL DISEASES (HANOI, VIETNAM) REPORTED A POTENTIAL FALSE NEGATIVE ESCHERICHIA COLI K1 (E. COLI K1) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CSF SAMPLE FROM A 67-YEAR-OLD, FEMALE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS HARMED AS A CONSEQUENCE OF THE ERRONEOUS RESULT. 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 |
|---|---|---|---|---|---|---|---|
| 1945884 | FILMARRAY ME PANEL | FILMARRAY ME PANEL | PLO | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0118 | 1047225 | 00815381020123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |