MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® BLOOD CULTURE IDENTIFICATION (BCID) PANEL

Model Number RFIT-ASY-0127

Device Problems False Negative Result (1225); False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Death (1802)

Event Date 06/18/2019

Event Type  Death  

Manufacturer Narrative

(b)(6) hospital ((b)(6)) reported false positive s.Marcescens and false negative p.Aeruginosa results on the filmarray bcid panel after testing a sample from a (b)(6) male patient.On (b)(6) 2019, a blood culture bottle (unknown type or lot number) rang positive after 30 hours in the bact/alert system.A filmarray bcid panel was performed 2 hours later and the result was positive for s.Marcescens and negative for p.Aeruginosa.Gram stain showed gram negative bacilli.This filmarray bcid panel result was reported to the physician.A confirmatory culture was performed and identified p.Aeruginosa using both vitek® and maldi-tof.A pure colony was also subcultured onto chromid® carba and identified as p.Aeruginosa.Because the results between the filmarray bcid panel and culture differed, the same sample was repeated on the filmarray bcid panel on (b)(6) 2019 and the result was again positive for s.Marcescens and negative for p.Aeruginosa.On (b)(6) 2019, biofire was informed that the patient expired.Information on the impact of the filmarray result on the patient outcome (i.E.Treatment timeline and modifications to patient care), clinical signs and symptoms, the site's decontamination and contamination prevention policies were all requested, but no further information has been provided to date.The isolate and blood culture bottle were requested for laboratory investigation; it is unknown if they are still available.Quality control (qc) records for pouch lot# 393019 (kit lot# 0004719) were reviewed.This pouch lot passed qc criteria and was found within specifications.No run malfunction was observed and the filmarray instrument (serial# (b)(4)) was working within specification.Based on the information provided, internal investigation concluded that the most likely cause for the false positive s.Marcescens and false negative p.Aeruginosa results was a known cross-reactivity between the s.Marcescens assay and a p.Aeruginosa strain that also exhibits reduced reactivity with the p.Aeruginosa assay.In the filmarray bcid panel instruction booklet, table 72 shows organisms that may potentially cross-react with the s.Marcescens assay.This table indicates cross-reactivity has been observed between the s.Marcescens assay and a specific strain of p.Aeruginosa (atcc 25619).Additionally, table 58 shows that the p.Aeruginosa strain atcc 25619 amplified less efficiently for the p.Aeruginosa assay but was detected at positive blood culture levels in that study (https://www.Online-ifu.Com/iti0045).It is possible that a similar strain of p.Aeruginosa was encountered in this case.Results from the filmarray bcid panel must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Clinical performance of the filmarray bcid panel p.Aeruginosa assay, as compared to standard manual/automated microbiological/biochemical identification, showed a sensitivity of 98.1% (95% ci 89.7-100%) and a specificity of 99.9% (95% ci 99.7-100%) (table 22,of the filmarray bcid panel instruction booklet).Inclusivity testing detected p.Aeruginosa at a concentration of 1x10^8 cfu/ml (table 58 of the filmarray bcid panel instruction booklet, https://www.Online-ifu.Com/iti0045).Clinical performance of the filmarray bcid panel s.Marcescens assay, as compared to standard manual/automated microbiological/biochemical identification, showed a sensitivity of 98.7% (95% ci 93.0-100%) and a specificity of 99.9% (95% ci 99.7-100%) (table 22 of the filmarray bcid panel instruction booklet).Inclusivity testing detected s.Marcescens at a concentration of 1x10^8 cfu/ml (table 55 of the filmarray bcid panel instruction booklet, https://www.Online-ifu.Com/iti0045).

Event Description

(b)(6) hospital ((b)(6)) reported discrepant serratia marcescens and pseudomonas aeruginosa results on the filmarray blood culture identification (bcid) panel after testing a patient sample.The patient ultimately expired.It is unknown if the filmarray bcid panel results affected patient care or patient outcome.Upon investigation, no malfunction occurred and the system was working within specification.The investigation concluded that the most likely cause for this discrepant result was a known cross-reactivity between the s.Marcescens assay and a p.Aeruginosa strain with reduced reactivity for the p.Aeruginosa assay (a similar strain was tested during performance evaluations and is detailed in the ifu).

Manufacturer Narrative

On july 18, 2019, biofire diagnostics, llc submitted a report (reference# 3002773840-2019-00005) involving a patient death and a potential positive false positive s.Marcescens and false negative p.Aeruginosa result on the filmarray blood culture identification (bcid) panel.Since submitting this report, biofire received communication from (b)(6) hospital ((b)(6), italy) confirming that the cause of death, a cerebral hemorrhage, was not related to the filmarray bcid panel result.

• Brand Name: FILMARRAY® BLOOD CULTURE IDENTIFICATION (BCID) PANEL
• Type of Device: FILMARRAY® BLOOD CULTURE IDENTIFICATION (BCID) PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow drive; salt lake city UT 84108
• MDR Report Key: 8804603
• MDR Text Key: 151503000
• Report Number: 3002773840-2019-00005
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00815381020093
• UDI-Public: 00815381020093
• Combination Product (y/n): N
• PMA/PMN Number: K181493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Model Number: RFIT-ASY-0127
• Device Catalogue Number: RFIT-ASY-0127
• Device Lot Number: 0004719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR