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

Model Number RFIT-ASY-0126

Device Problem False Positive Result (1227)

Patient Problem Renal Failure (2041)

Event Date 03/15/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: (b)(6) hospital and medical center ((b)(6)) reported potential (b)(6) results on the filmarray® bcid panel after testing a sample from a (b)(6)-year-old, female patient.The patient had symptoms of leukocytosis, hypotension, weakness, fatigue, and acute kidney injury (aki).The sample was cultured using biomerieux bact/alert® sa culture bottles (lot# unknown).The bottle was collected on (b)(6) 2020 at 8:50 pm and rang positive on (b)(6) 2020 at 12:13 pm on (b)(6) 2020, the sample was tested on the filmarray bcid panel and was (b)(6) for staphylococcus aureus and (b)(6).The sample was gram stained and had gram-positive cocci in clusters.The sample was cultured and detected staphylococcus by latex testing.The sample was tested using vitek® ast-gp75 susceptibility card with a cefoxitin screen negative.It was also tested by kb disk diffusion and had a cefoxitin zone of 25mm and was sensitive.The sample was retested on the filmarray bcid panel on (b)(6) 2020 and had a (b)(6) s.Aureus and (b)(6) result.The same sample was used for all testing.Due to the filmarray bcid panel results, the patient was treated with broad coverage vancomycin.The patient was treated for 6 weeks because it was unclear if the patient could safely be de-escalated to a narrower spectrum agent due to the discordant results.The patient experienced a possible adverse treatment affect where the serum creatinine (scr) rose from 1.2 to 2.4 while finishing the vancomycin treatment at an outside facility.According to the customer, the patient's "kidney function was impaired and the vancomycin dose was adjusted accordingly." the customer reported that they did not know if the kidney impairment has been fully resolved as the patient was discharged from the hospital and is being managed by an outside external care facility.The customer stated that they would have treated with a less nephrotoxic drug if the results had been (b)(6) for (b)(6).When asked about their test preparation methods, the customer stated that pouches are setup according to the filmarray bcid panel quick guide.The customer decontaminates the biosafety cabinet work area and pouch-loading stations with 10% bleach followed by a 70% alcohol wipe.This biosafety cabinet is also used for the preparation of nasopharyngeal samples for flu pcr rsv antigen and covid testing as well as stool samples for c.Difficile and norovirus pcr.Quality control (qc) records for pouch lot# 104119 (kit lot#1190119) were reviewed.This pouch lot passed qc criteria and was found within specification.No run malfunction was detected and the fimarray instrument (serial# (b)(4)) was working within design specifications.Conclusion: based on the information provided, the investigation concluded that the most likely cause for the discrepant meca results were sensitivity/specificity differences between the filmarray bcid panel and the comparator methods with a polymicrobial specimen.Since the filmarray bcid panel detects organisms directly from blood culture bottles rather than isolated colonies, discrepancies with standard identification techniques can occur and are a part of normal system performance.The filmarray bcid panel run files suggest that this may have been a polymicrobial specimen, where the bottle could have been driven to positivity by a high titer s.Aureus which could have outgrown another staphylococcus species containing the (b)(6).It is also possible that there was a heterogeneous population of s.Aureus, where a small portion of the population carried the (b)(6).The staphylococcus species containing the (b)(6) may not have been at a titer that was detectable by culture.As stated in the filmarray bcid panel instruction booklet [rfit-prt-0369], the filmarray bcid panel may not distinguish mixed cultures when two or more species of the same genus or organism group are present in a specimen (e.G., s.Aureus and s.Epidermidis).According to table 26 of the filmarray bcid panel instruction booklet [rfit-prt-0369], the performance claim for the (b)(6) assay in staphylococcus, s.Aureus detected specimens compared to phenotypic ast methods showed a ppa of 97.7% (95% ci 93.4-99.5%) and an npa of 96.7% (95% ci 91.7-99.1%).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.In mixed growth, the filmarray bcid panel does not specifically attribute meca-mediated methicillin resistance to either s.Aureus or other staphylococcus sp.

Event Description

Summary: (b)(6) hospital and medical center ((b)(6)) reported discrepant meca results on the filmarray® blood culture identification (bcid) panel after testing a sample from a (b)(6)-year-old, female patient.Due to the filmarray bcid panel results, the patient was treated with vancomycin for 6 weeks.Later in the course of therapy the patient experienced a permanent kidney function impairment that was caused in part by the treatment of vancomycin.Upon investigation, no malfunction occurred and the system was working within specification.The investigation concluded that the most likely cause for the meca discrepant result was sensitivity/specificity differences between the filmarray bcid panel and comparator methods with a polymicrobial specimen.

• Brand Name: FILMARRAY® BLOOD CULTURE IDENTIFICATION PANEL
• Type of Device: FILMARRAY® BLOOD CULTURE IDENTIFICATION PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow drive; salt lake city, ut
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 515 colorow drive; salt lake city, ut
• Manufacturer Contact: kristen kanack ; 515 colorow drive; salt lake city, ut ; 7366354133
• MDR Report Key: 10080024
• MDR Text Key: 195002449
• Report Number: 3002773840-2020-00002
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00815381020086
• UDI-Public: 00815381020086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/04/2020
• Device Model Number: RFIT-ASY-0126
• Device Catalogue Number: RFIT-ASY-0126
• Device Lot Number: 1190119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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: 73 YR