MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL; FILMARRAY ME PANEL

Model Number ME PANEL V1.4

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problems Neurological Deficit/Dysfunction (1982); Meningitis (2389)

Event Date 07/16/2016

Event Type  Injury  

Manufacturer Narrative

Publication referenced: gomez, c.A., pinsky, b.A., liu, a., banaei, n., delayed diagnosis of tuberculous meningitis misdiagnosed as herpes simplex virus-1 (hsv-1) encephalitis with the filmarray syndromic pcr panel.Open forum infectious diseases advance access published december 8, 2016.The publication was brought to our attention on december 15, 2016.Of note, the publication incorrectly stated that the initial testing site did not perform confirmation testing of the hsv-1 filmarray me panel result.O'connor hospital reported to biofire diagnostics that they had sent out the specimen for confirmation testing (result negative for hsv-1).O'connor hospital reported that they collected a second lumbar puncture specimen for filmarray me panel testing 9 days after the first test (result negative for all analytes).This was also omitted from the publication.A run file for this second test was provided to biofire and appeared normal.It is unclear in the publication and in discussions with the sites, whether the residual csf specimen testing performed by the second site was from the first or second lumbar puncture.Device not returned.Software runfile evaluated.

Event Description

A report was published indicating that a delayed diagnosis of tuberculous meningitis had occurred in a patient due to a filmarray meningitis/encephalitis (me) panel positive test result for herpes simplex virus 1 (hsv-1).The specimen was sent out to another institution for confirmation of hsv-1; the result was negative for hsv-1 (method unknown).Concomitant csf and blood cultures reported no growth.The patient was placed on iv acyclovir therapy, but their mental status continued to decline.A second csf specimen was tested on the filmarray me panel after 9 days; the result was negative for hsv-1.The patient was transferred to a second facility after 10 days.At the second facility, hsv-1/hsv-2 real-time pcr was negative, but pcr testing for mycobacterium tuberculosis was positive (after 7 days).Treatment with isoniazid, rifampin, pyrazinamide and ethambutol (first-line drugs)was initiated.Csf culture (mgit medium) became positive for m.Tuberculosis after 13 days; the isolate was pan-susceptible to first line drugs.The patient experienced severe neurological sequelae from m.Tuberculosis infection, requiring a tracheostomy and gastric feeding tube.The patient has exhibited improvement since the literature publication, although residual neurological sequelae remain.Residual csf from the initial facility was tested by the second facility: filmarray me panel (negative), hsv-1 real-time pcr (negative), and m.Tuberculosis pcr (positive).The filmarray me panel test run file was examined and showed normal signal indicating a very low level of hsv-1 had been detected.No malfunctions were apparent.No false positive hsv-1 results were observed in qc testing of this reagent lot.Complaint trending showed false positive rates within claimed performance.Low level hsv-1 may be present due to latency or reactivation, or introduced into the sample during collection or into the reagent during manufacturing or testing.The source of the detected analyte in this instance cannot be determined.

• Brand Name: FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL
• Type of Device: FILMARRAY ME PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 390 wakara way; salt lake city UT 84108
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 390 wakara way; salt lake city UT 84108
• Manufacturer Contact: kristen kanack ; 390 wakara way; salt lake city, UT 84108 ; 8017366354
• MDR Report Key: 6247645
• MDR Text Key: 64713603
• Report Number: 3002773840-2017-00001
• Device Sequence Number: 1
• Product Code: PLO
• UDI-Device Identifier: 00815381020123
• UDI-Public: (01)00815381020123(17)170211(10)414316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN150013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2017
• Device Model Number: ME PANEL V1.4
• Device Catalogue Number: RFIT-ASY-0118
• Device Lot Number: KIT LOT# 414316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR; ACYCLOVIR; CASPOFUNGIN; DEXAMETHASONE; ETHAMBUTOL; ISONIAZID; IV ZOSYN; LEVOFLOXACIN; MEROPENEM; PYRAZINAMIDE; RIFAMPIN; VANCOMYCIN
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 75