FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL

Report

Report Number: 3002773840-2025-00077
Event Type: Death
Date Received: November 6, 2025
Date of Event: August 18, 2025
Report Date: November 20, 2025
Manufacturer: BIOFIRE DIAGNOSTICS, LLC
Product Code: PLO
UDI-DI: 00815381020123
PMA / PMN Number: K160462
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION: THE PATIENT WAS A 79-YEAR-OLD FEMALE. THE PATIENT PRESENTED WITH SYMPTOMS OF IMPAIRED VIGILANCE, CONVULSIVE SEIZURES, AND A FEVER WITH AN ONSET OF (B)(6) 2025. THE PATIENT HAD A CT SCAN OF THE HEAD PERFORMED ON (B)(6) 2025. THE PATIENT ALSO HAD CIRRHOSIS. ON (B)(6) 2025, A CSF SAMPLE WAS COLLECTED AND TESTED ON THE FILMARRAY ME PANEL AT THE VILLEFRANCHE LOCATION. THE ME PANEL REPORTED HSV-1 AS NOT DETECTED. THE CSF PARAMETERS WERE AS FOLLOWS: 7 LEUKOCYTES, 570 RED BLOOD CELLS, CSF PROTEIN 4.81, CSF GLUCOSE 4.09 MMOL/L. ON (B)(6) 2025, A COMPARATOR SIMPLEX PCR TEST, ELITE BEGENIUS®, WAS PERFORMED AND WAS NEGATIVE FOR HSV-1. THE PATIENT HAD A GLASGOW COMA SCALE OF 14 AND WAS INTUBATED AND VENTILATED IN INTENSIVE CARE IN LYON. THE NEGATIVE RESULT FOR HSV-1 WAS REPORTED TO THE PHYSICIAN. ON (B)(6) 2025, A SECOND CSF SAMPLE WAS COLLECTED AND TESTED ON THE FILMARRAY ME PANEL AT THE LYON LOCATION. THE ME PANEL REPORTED HSV-1 AS NOT DETECTED. THE CSF PARAMETERS WERE AS FOLLOWS: <2 LEUKOCYTES, 150 RED BLOOD CELLS, CSF PROTEIN 0.55, CSF GLUCOSE AT 3.4 MMOL/L. ON (B)(6) 2025, ELITE BEGENIUS® WAS PERFORMED ON A SEPARATE TUBE FROM THE SAME SAMPLE COLLECTION AND WAS NEGATIVE FOR HSV-1. A BRAIN MRI SHOWED RIGHT INSULAR AND RIGHT INTERNAL TEMPORAL CYTOTOXIC LESIONS CONSISTENT WITH ENCEPHALITIC INVOLVEMENT, PARTICULARLY HSV. THE NEGATIVE RESULTS FOR HSV-1 WERE REPORTED TO THE PHYSICIAN. ON (B)(6) 2025, THE PATIENT RECEIVED ONE DOSE OF ACYCLOVIR AT 10 MG/KG/ 8H FOR LESS THAN 24 HOURS. TREATMENT WAS STOPPED DUE TO THE NEGATIVE HSV-1 RESULTS FROM THE ME PANEL AND AFTER ACUTE RENAL FAILURE. ON (B)(6) 2025, A THIRD CSF SAMPLE WAS COLLECTED AND TESTED ON THE FILMARRAY ME PANEL AT THE LYON LOCATION. THE ME PANEL REPORTED HSV-1 AS NOT DETECTED. THE CSF PARAMETERS WERE AS FOLLOWS: <2 LEUKOCYTES, <100 RED CELLS, CSF PROTEIN 0.88, CSF GLUCOSE AT 3.7 MMOL/L. THE NEGATIVE RESULT FOR HSV-1 WAS REPORTED TO THE PHYSICIAN. ON (B)(6) 2025, ELITE BEGENIUS® WAS PERFORMED ON THE SAME SAMPLE FROM (B)(6) 2025, DUE TO STRONG SUSPICION OF HSV-1 AND WAS POSITIVE FOR HSV-1 WITH A Q COP/ML OF 339. THE POSITIVE HSV-1 RESULT WAS REPORTED TO THE PHYSICIAN. ON THIS SAME DAY, ACYCLOVIR TREATMENT WAS RESUMED AT A DOSE OF 10 MG/KG/8H. AFTER THE POSITIVE RESULT WAS RECEIVED, THE CUSTOMER RETROSPECTIVELY TESTED THE CSF SAMPLE COLLECTED ON (B)(6) 2025, WITH ELITE BEGENIUS®. THE TEST WAS POSITIVE FOR HSV-1 WITH A Q COP/ML OF 147. ON (B)(6) 2025, A FOURTH CSF SAMPLE WAS COLLECTED AND TESTED ON THE FILMARRAY ME PANEL AT THE LYON LOCATION. THE ME PANEL REPORTED HSV-1 AS DETECTED. THE CSF PARAMETERS WERE AS FOLLOWS: <2 LEUKOCYTES, <100 RED BLOOD CELLS, CSF PROTEIN 1.25, CSF GLUCOSE AT 3.4 MMOL/L. THE POSITIVE RESULT FOR HSV-1 WAS REPORTED TO THE PHYSICIAN. ON THAT SAME DAY, THE SAME SAMPLE WAS TESTED WITH ELITE BEGENIUS®. THE TEST WAS POSITIVE FOR HSV-1 WITH A Q COP/ML OF 3415. A BRAIN AND SPINAL CORD MRI SHOWED INCREASED VISIBILITY OF PRE-EXISTING RIGHT TEMPORO-INSULAR PARENCHYMAL LESIONS AND APPEARANCE OF BILATERAL PARIETAL CORTICAL LESIONS WITH HIGH SIGNAL INTENSITY ON DIFFUSION-WEIGHTED IMAGING. ON (B)(6) 2025, THE ACYCLOVIR DOSAGE FREQUENCY WAS REDUCED TO 10 MG/KG/12HR FOLLOWING RENAL FAILURE. THE PATIENT¿S FINAL DIAGNOSIS WAS HERPETIC ENCEPHALITIS. THE CUSTOMER REPORTED THAT DUE TO THE FILMARRAY ME PANEL RESULTS, THE PATIENT¿S TREATMENT WITH ACYCLOVIR WAS DISCONTINUED AND RESTARTED 3 DAYS LATER FOLLOWING THE ELITE BEGENIUS® RESULT. ON (B)(6) 2025, THE PATIENT DIED. THE PATIENT¿S FINAL CAUSE OF DEATH WAS HERPES ENCEPHALITIS PROGRESSING TO EXTENSIVE LESIONS UNDER TREATMENT. DECOMPENSATION OF CIRRHOSIS: HEPATIC ENCEPHALOPATHY AND DECOMPENSATED EDEMA AND ASCITES. VENTILATOR-ASSOCIATED PNEUMONIA THE ANALYSIS OF THE FILMARRAY ME PANEL RUN FILES FROM AUGUST (B)(6) SHOWED A COMPLETELY FLATLINE SIGNATURE FOR THE HSV-1 TARGET, SUGGESTING THAT ORGANISM/NUCLEIC ACID, IF PRESENT IN THE SAMPLE, WAS BELOW THE LIMIT OF DETECTION THE ANALYSIS OF THE FILMARRAY ME PANEL RUN FILE FROM (B)(6) SHOWED A LATE SIGNATURE, SUGGESTING THAT THERE WAS A LOW LEVEL OF ORGANISM/NUCLEIC ACID PRESENT IN THE SAMPLE. NO RUN FILE WAS PROVIDED FOR THE RUN PERFORMED ON (B)(6). QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3MVL25 (KIT LOT# 0094225) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE AND THE FILMARRAY INSTRUMENTS TM15646 AND TM08944 WERE WORKING WITHIN DESIGNED SPECIFICATIONS. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE HSV-1 FALSE NEGATIVES WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND ELITE BEGENIUS® COMPARATOR PCR TESTING WITH A LOW-LEVEL ANALYTE CONCENTRATION. IT IS LIKELY THAT A LOW LEVEL OF HSV-1 TARGET NUCLEIC ACID/ORGANISM WAS PRESENT IN THE FIRST THREE LUMBAR PUNCTURE SAMPLES. THE FILMARRAY ME PANEL'S LIMIT OF DETECTION (LOD) FOR HSV-1 IS 1510 COPIES/ML, SEE TABLE 17 IN THE FILMARRAY ME PANEL INSTRUCTION BOOKLET (HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/ALL?KEYCODE=ITI0035). THE COMPARATOR METHOD QUANTIFIED BOTH THE SECOND AND THIRD LUMBAR PUNCTURE BELOW THE LOD OF THE ME PANEL. THE DETECTION OF AN ORGANISM OR ITS NUCLEIC ACID AT A LOW CONCENTRATION IN THE SAMPLE CAN VARY FROM POUCH TO POUCH, AND A FILMARRAY ANALYTE NEAR THE LOD OF THE ME PANEL MAY NOT ALWAYS BE DETECTED UPON RETESTING. THE ME PANEL DETECTED HSV-1 IN THE FOURTH LUMBAR PUNCTURE SAMPLE, AND THE SAMPLE WAS QUANTIFIED ABOVE THE LOD OF THE FILMARRAY ME PANEL. THE FILMARRAY ME PANEL IS A QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED IN VITRO DIAGNOSTIC CAPABLE OF THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF MULTIPLE BACTERIAL, VIRAL, AND YEAST NUCLEIC ACIDS DIRECTLY FROM CEREBROSPINAL FLUID (CSF) SPECIMENS OBTAINED VIA LUMBAR PUNCTURE FROM INDIVIDUALS WITH SIGNS AND/OR SYMPTOMS OF MENINGITIS AND/OR ENCEPHALITIS. WHILE RARE, DISCREPANCIES BETWEEN BIOFIRE® FILMARRAY® AND OTHER PCR METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT OBSERVED IN THE FIELD. THESE DISCREPANCIES CAN BE CAUSED BY DIFFERENCES IN CHEMISTRIES, ORGANISM TARGETS, PROCEDURES, SOFTWARE ANALYSIS, AND ASSAY CUT-OFF THRESHOLDS. DETECTION OF TARGET NUCLEIC ACID IS DEPENDENT UPON PROPER HANDLING, STORAGE, AND 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 BIOFIRE® FILMARRAY® SHOULD BE USED IN CONJUNCTION WITH AND CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT IT SHOULD BE NOTED THAT RESULTS FROM DIFFERENT SAMPLES CANNOT BE DIRECTLY COMPARED DUE TO INHERENT VARIABILITY BETWEEN SPECIMENS. SAMPLE-TO-SAMPLE VARIABILITY WITHIN CONTAINERS FROM THE SAME COLLECTION EVENT CAN INCLUDE DIFFERENCES IN ORGANISM CONCENTRATION AND OTHER FACTORS. ADDITIONALLY, COMPARING DIFFERENT SAMPLES IS NOT RECOMMENDED AS OUTCOMES MAY NOT BE REPRODUCIBLE. PCR PERFORMANCE CAN BE INFLUENCED BY THE AMOUNT OF GENETIC MATERIAL PRESENT IN THE SAMPLE, WHICH CAN BE AFFECTED BY ONGOING AND/OR RECENT TREATMENT (SUCH AS THE ACYCLOVIR ADMINISTRATION IN THIS CASE). FILMARRAY® ME PANEL RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER INFORMATION AVAILABLE TO THE CLINICIAN. 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 9 AND 14 OF THE FILMARRAY ME PANEL INSTRUCTION BOOKLET (HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/ALL?KEYCODE=ITI0035); WHILE THE LIMIT OF DETECTION (LOD) VALUES FOR THE ANALYTES ON THE FILMARRAY ME PANEL CAN BE FOUND IN TABLE 17.

Additional Manufacturer Narrative · 0

INVESTIGATION: HOSPITAL (B)(6), REPORTED SEVERAL POTENTIAL FALSE NEGATIVE HSV-1 RESULTS ON THE ME PANEL AFTER TESTING MULTIPLE CSF SAMPLES FROM A 79-YEAR-OLD FEMALE PATIENT. ON (B)(6) 2025, THE FILMARRAY ME PANEL REPORTED A NEGATIVE RESULT FOR HSV-1. ON (B)(6) 2025, TREATMENT WITH ACICLOVIR WAS INITIATED. ON THE SAME DAY, TREATMENT WITH ACICLOVIR WAS STOPPED DUE TO A SECOND NEGATIVE HSV-1 RESULT ON THE FILMARRAY ME PANEL. ON (B)(6) 2025, ACICLOVIR WAS RESUMED DUE TO THE STRONG SUSPICION OF ENCEPHALITIS AND A POSITIVE HSV-1 PCR TEST BY ELITE BEGENIUS®. ON (B)(6) 2025, THE PATIENT DIED. 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.

Description of Event or Problem · 0

SUMMARY: (B)(6) REPORTED SEVERAL POTENTIAL FALSE NEGATIVE HSV-1 RESULTS ON THE FILMARRAY ME PANEL AFTER TESTING A CSF SAMPLE FROM A 79-YEAR-OLD FEMALE PATIENT. DUE TO THE ME PANEL RESULTS, ACYCLOVIR TREATMENT WAS PAUSED FOR THREE DAYS. ACYCLOVIR TREATMENT RESUMED AFTER THREE DAYS. THE PATIENT DIED APPROXIMATELY TWO WEEKS LATER. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE HSV-1 FALSE NEGATIVES WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE FILMARRAY ME PANEL AND ELITE BEGENIUS® COMPARATOR PCR TESTING WITH A LOW-LEVEL ANALYTE CONCENTRATION.

Description of Event or Problem · 0

SUMMARY: HOSPITAL (B)(6), REPORTED SEVERAL POTENTIAL FALSE NEGATIVE HSV-1 RESULTS ON THE ME PANEL AFTER TESTING MULTIPLE CSF SAMPLES FROM A 79-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS TREATED INAPPROPRIATELY AS TREATMENT WITH ACICLOVIR WAS STOPPED FOR THREE DAYS. THE PATIENT LATER DIED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. 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
2693238	FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL	FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL	PLO	BIOFIRE DIAGNOSTICS, LLC	RFIT-ASY-0118	0094225	00815381020123

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR	Female	Death