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

Model Number ME PANEL V1.4

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Encephalitis (2429)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

According to the filmarray me panel's limitation section (listed in the instructions for use), negative results from the filmarray me panel can occur due to the presence of sequence variants or rearrangements in the gene targets of the assay, inhibitors in specimens, technical error or infection caused by an organism not detected by the filmarray me panel.Filmarray results may also be affected by concurrent antimicrobial therapy or levels of organism in the sample that are below the limit of detection.Negative pcr results for hsv-1 can also occur due to the time latency between the onset of neurological symptoms and csf collection or by the presence of inhibitory compounds in the csf.A negative filmarray me hsv-1 result may only be used with moderate confidence to rule out a cns viral infection and should not be used as the sole basis for diagnosis, treatment, or other management decisions.Results from the me panel must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Table 17 of the me panel instruction booklet shows the hsv-1 strains and their limit of detection tested during the analytical testing for the me panel.Analytical and clinical performance for the hsv-1 assay showed a lod of 250 tcid50/ml (1.51 x 10^3 copies/ml) with a ppa of 100% (95% ci 80.6-100) and a npa of 99.4% (95% ci 97.3-100).

Event Description

A patient showing characteristic symptoms of (b)(6) encephalitis and a left temporal lobe lesion was admitted to the customer site hospital ((b)(6) medical center) on (b)(6) 2017.The patient was placed on antiviral treatment (b)(6) upon admittance.The following day, and under antiviral treatment, two csf tubes were collected from the patient via lumbar puncture.One tube was tested on the filmarray me panel on (b)(6) 2017, resulting in (b)(6) interpretations for all assays.(b)(6) treatment was not discontinued based on the filmarray result.The same sample was tested using an in-house laboratory test specific for (b)(6) and reported (b)(6) result.The second csf tube obtained on the same collection event was tested on filmarray on (b)(6) 2017 and reported (b)(6) for (b)(6).Patient care was not affected as the treatment was continued despite the (b)(6) result.Upon follow up communication with the customer on (b)(6) 2017, the patient has made significant recovery but still suffers from some tremors and memory loss.The customer has sent an aliquot of the csf sample to biofire for an internal investigation.Qc records for kit lot 638817 were reviewed and no unexpected results were observed.This lot passed the qc criteria and was found within specifications.No run malfunction was observed and filmarray instruments 2fa01040 and 2fa00917 (located at (b)(6) medical center) were working within design specifications.Historical qc records for the filmarray me panel showed a (b)(6) for (b)(6) of (b)(6) during qc testing.Current field reports for the filmarray me panel in 2017 showed a (b)(6) for (b)(6).Based on the information provided to biofire, the most likely cause for the initial (b)(6) result was the presence of (b)(6) concentration below filmarray's limit of detection.Detection of an organism with a low sample concentration might vary from pouch to pouch and system to system and discrepant results upon retest are not uncommon.

• Brand Name: FILMARRAY MENINGITIS/ENCEPHALITIS PANEL
• Type of Device: FILMARRAY ME PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow drive; salt lake city UT 84108
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 515 colorow drive; salt lake city UT 84108
• Manufacturer Contact: kristen kanack ; 515 colorow drive; salt lake city, UT 84108 ; 8017366354
• MDR Report Key: 7659195
• MDR Text Key: 113071098
• Report Number: 3002773840-2017-00002
• Device Sequence Number: 1
• Product Code: PLO
• UDI-Device Identifier: 00815381020123
• UDI-Public: 00815381020123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: ME PANEL V1.4
• Device Catalogue Number: RFIT-ASY-0118
• Device Lot Number: KIT LOT# 638817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR