MAUDE Adverse Event Report: ACCELERATE DIAGNOSTICS, INC. ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT; ACCELERATE PHENO¿ SYSTEM

Model Number	10401008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Therapeutic Response, Increased (2272); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accelerate pheno¿ system is a fully-integrated in vitro diagnostic system comprised of one to eight id/ast module(s), a computing system, touchscreen monitor and accelerate pheno¿ system software for use with accelerate phenotest¿ kits.It is designed to perform identification (id) of bacterial and yeast cells and antimicrobial susceptibility testing (ast) in approximately 7 hours directly from positive blood culture samples.Accelerate diagnostics opened an investigation after receiving a complaint.Run data and images obtained from the accelerate pheno¿ system run in question were reviewed.The conclusion was that the sample contained a high amount of debris in the pseudomonas aeruginosa (pae) channel and very few rods were observed in the escherichia coli channel (below the limit of detection).As part of the investigation, the sample was sent to accelerate diagnostics, inc.For discrepancy testing.Testing was completed using mald-tof, and results confirmed the sample contained escherichia coli only.Negative sample testing was also performed to determine if the pae probe contains debris that could cause false positive results.Negative sample testing demonstrated that the probe does not contain debris.Root cause of the false-positive pae was determined to be debris in the pae channel, yet cause of the debris cannot be determined.False positives are inherent to the device and included in the labeling.
Event or Problem Description
The accelerate pheno¿ system reported pseudomonas aeruginosa (false positive).The patient received an escalation of antibiotics, an id consult, and ct chest/abdomen/pelvis to identify the source of the infection.The comparator method (maldi-tof) identified escherichia coli.A patient admitted with ascending cholangitis had blood cultures taken for identification (id)and antimicrobial susceptibility testing (ast).The accelerate pheno¿ system id result indicated that the patient was infected with drug-resistant pseudomonas aeruginosa.In response, antibiotic treatment was escalated using cefepime, an id consult was initiated, and the patient received a ct chest/abdomen/pelvis to identify the source of the pae infection and determine whether it was present on the patient's spinal hardware.After 24 hours, comparative test (mald-tof) results identified the bacteria as escherichia coli, not pseudomonas aeruginosa.Patient therapy was then deescalated to oral ciprofloxacin.The patient responded well and was discharged on the oral ciprofloxacin.

• Brand Name: ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT
• Common Device Name: ACCELERATE PHENO¿ SYSTEM
• Manufacturer (Section D): ACCELERATE DIAGNOSTICS, INC.; 3950 s country club rd. #470; tucson AZ 85714
• MDR Report Key: 9227519
• Report Number: 3010671651-2019-00001
• Device Sequence Number: 11315056
• Product Code: PRH
• UDI-Device Identifier: 00862011000314
• UDI-Public: 00862011000314
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2020
• Device Model Number: 10401008
• Device Catalogue Number: 10101018
• Device Lot Number: 3715A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 46 YR
• Patient Weight: 64