FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815381020130), received between Sep 9, 2018 and Feb 15, 2019 — classified as 2 deaths.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathFeb 15, 2019False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER (THROUGH (B)(4)) REPORTED A DISCREPANT CRYPTOCOCCUS NEOFORMANS/GATTII (C. NEOFORMANS/GATTII) RESULT ON THE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A CEREBROSPINAL FLUID (CSF) SAMPLE FROM A (B)(6), IMMUNOCOMPROMISED, MALE PATIENT. ACCORDING TO THE CUSTOMER, THE DISCREPANT FILMARRAY ME PANEL RESULT LED TO INAPPROPRIATE PATIENT TREATMENT, SUBSEQUENT PATIENT DETERIORATION AND DEATH. UPON INVESTIGATION, IT WAS FOUND THAT NO MALFUNCTION OCCURRED AND THE FILMARRAY ME PANEL SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSES FOR THE DISCREPANT RESULT WERE: SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN ANTIGEN AND PCR METHODS, AND/OR SAMPLE HANDLING ERROR.

  Patient problems: Death

  MAUDE report 8345345 ↗
• DeathSep 9, 2018False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(6) REPORTED A DISCREPANT CRYPTOCOCCUS RESULT ON THE FILMARRAY MENINGITIS/ ENCEPHALITIS (ME) PANEL USING A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE. PATIENT CARE WAS AFFECTED DUE TO THE FILMARRAY RESULTS. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS DUE TO LOW LEVEL ORGANISM IN THE SAMPLE AND COMPARATOR SENSITIVITY/SPECIFICITY DIFFERENCES. ON (B)(6) 2018, BIOFIRE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THE PATIENT HAD DIED. BIOFIRE HAS REQUESTED ADDITIONAL INFORMATION ABOUT THE CAUSE OF DEATH, BUT HAS NOT RECEIVED ADDITIONAL INFORMATION. BIOFIRE HAS NO INFORMATION TO SUGGEST THAT USE OF THE FILMARRAY ME PANEL CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Death; Meningitis

  MAUDE report 7858817 ↗